VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 29, 2015 4:48 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

Dear Madam Secretary Burwell,

I’d like to take a moment to commend and compliment Ms. Gaetana Marshall, M.S. Health Insurance Specialist out of your Atlanta, GA regional office for the time and effort she put into listening to my explanations and researching the document(s) you folks in D.C. recently sent to her office relating to my supposed issue(s) that I have been advocating to resolve these past two years.  Ms. Marshall in turn forwarded the documents (copy and pasted below) for me to read and I in turn share for everyone’s perusal.  At the same time I would also like to acknowledge the concerted efforts on the part of Ms. Courtney S. Turner, MPH - Office of Hearings and Inquiries, Medicare Ombudsman Group, Division of Medicare Ombudsman Assistance who respectfully assisted in my advocacy and has helped several of the VNS Depression patients receive medical care these past couple of years and to Ms. Stephany Terry – CMS for following up on my telephone call to Ms. Lisa Spradlin – CMS yesterday in the absence of Ms. Courtney Turner. 

I’m sure Madam Secretary that you are familiar with these famous words, “Houston, we have a problem!”  And shortly thereafter the intellectual minds at another of our government agencies, NASA, effectively, efficiently and expeditiously went to work solving a life and death crisis in a matter of days.

Well Madam Secretary I’ve come to the conclusion the same is not true for your agencies handling and effectiveness as it relates to the health care for the implanted VNS Depression patients.

In fact what I discern in this instance is “HHS/CMS we have a failure to communicate!” as well as what appears to be a classic illustration of the Tower of Babel.

In absolutely none of my advocacy/activism these past two (2) years have I advocated for approval of the VNS Therapy for Depression or the reversal of the May 4, 2007 denial.  That is the responsibility of the sponsor, Cyberonics and yet the communications I constantly receive from your agency refer me to the CMS denial decision of May 4, 2007.  Believe me I’ve carefully read that decision a number of times and I am cognizant of its contents.

What I specifically and rightfully have advocated for is care and health insurance coverage which CMS egregiously, immorally and/or unconscionably omitted or overlooked in that decision whether through ineptitude, ignorance or failure to grandfather-in-care for all the study subjects and patients implanted with this medical device prior to May 4, 2007 in accordance with the doctrine of “Continuity of care” contained in several CMS documents.

Obviously not all your subordinates understand, comprehend or obtained any message that CMS recognizes and acknowledges the medical doctrine of “Continuity of Care” as was reiterated by CMS most recent DBA adjudicated decision of December 30, 2014. These patients are rightfully to be cared for and covered by medical insurance.  The CMS decision of May 4, 2007 does not apply to these previously implanted patients.  Is that too difficult for your people to read and comprehend?

Page 62

“With respect to those

beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for:  (1) “the

interrogation and calibration of a VNS therapy device implanted and deemed to be

reasonable and medically necessary when implanted for TRD”; or (2) “for the

replacement of the implanted pulse generator device upon battery expiration, when

required[.]”  AP Statement ¶ 43.  According to the Aggrieved Parties, those omissions

conflict with:  (1) “continuity of care” standards that are “widely accepted within the

medical community (i.e., a physician should not discontinue treatment that is effective for

a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is

unsafe for beneficiaries to have an implanted medical device that is not properly

calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements

wherein CMS has recognized that continuing Medicare coverage for beneficiaries who

received Medicare-covered durable medical equipment (DME) before it was non-covered

‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42

(quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).”

Page 63

“CMS states that it “leaves decisions

regarding the maintenance of already-implanted devices to contractor discretion” and that

such decisions “are, appropriately, made on an ad hoc basis after the local contractor’s

consideration of the applicable facts.”  Id. We understand from these representations that

CMS and its contractors do not, or will not in the future, apply NCD 160.18(C) to bar

coverage of maintenance services – including replacement of the implanted VNS device

upon battery expiration – for beneficiaries who received the VNS device prior to May 4,

2007.”

Yet I continue to receive communications from your agency citing the May 4, 2007 decision.  Obviously the proper communications from your office in the words of former President Regan are not having a “trickle down” effect.  For the umpteenth time please have your agency and your subordinates notify MAC, Regional Agencies, State Agencies, contractors etc., etc. that based upon the reaffirmation of the DBA adjudicated decision of December 30, 2014 that all VNS Depression patients implanted prior to May 4, 2007 are to be covered for medical care and health insurance coverage and there should be absolutely no need for these patients to have go through an appeals process as a result of your agencies inability to communicate this fact with one another.

Why must I continue to receive communications citing denials and reference to the May 4, 2007 as was recently illustrated in a communication dated July 17, 2015 from Kristen Dixon - Health Insurance Specialist - Atlanta Division of Financial Management & Fee for Service Operations (see below) and an earlier letter dated April 17, 2015 from Patrick Conway, MD, MSc - Acting Principal Deputy Administrator - Deputy Administrator for Innovation and Quality – CMS Chief Medical Officer (see below).

Why not a letter, directive or whatever document you issue to your MAC agencies, Regional office agencies, State Agencies, contractors etc., etc. apprising them of the doctrine of “Continuity of Care” and the DBA adjudicated decision of December 30, 2014 favorably affecting the VNS Therapy patients for depression?  Stop all this negativity, denials, oversight and appeal non-sense being referenced to the May 4, 2007 denial decision when in fact the December 30, 2014 decision clearly indicates these medical device implanted patients have rights to medical care and health insurance coverage.

And to those private health insurance CEO’s I have also addressed and hounded you too have unjustly denied care and medical insurance coverage to these patients and similarly you should be issuing directives to your staff that these patients should be properly cared for and rightly insured.    

Take a positive approach to wellness.  Advise all your agencies and health insurance carriers that the previously implanted VNS patients for depression are rightfully entitled to medical care and coverage without need for any denials or subsequent appeals!

Lastly, I’ll also take the liberty to remind you and all those agency staffers who read this communication:

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

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From: Marshall, Gaetana (CMS/CMHPO) [mailto:Gaetana.Marshall@cms.hhs.gov]
Sent: Tuesday, July 21, 2015 7:59 AM
To: Herbert Stein (fabrik@bellsouth.net)
Subject: C1502484607 Re. Mr. H. Stein

Good morning Mr. Stein,

Since our telephone conversation on Friday I have had an opportunity to follow up from discussions we had and to speak with a few of my CMS colleagues who have responsibility for standard Medicare A/B policy decisions.  Notably, I have spoken to Courtney Turner who works with the CMS Ombudsman team and the management team for Medicare A/B policy decisions.

They have provided me with the following items for your records and information:

A. A Beneficiary Casework Call (August 2014) presentation regarding VNS coverage.

B. A Sept. 24, 2013 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to the Honorable Debbie Wasserman Schultz on behalf of your wife regarding health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

C. The CMS Ombudsman’s response from January 2015 regarding the Division of Appeal Board’s (DAB) decision.

D. The April 17, 2015 letter from the CMS Center for Clinical Standards and Quality formally responding to you (on behalf of Secretary of Health and Human Services) regarding the DAB decision.

E. A July 17, 2015 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to you regarding the health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

The documents above are official CMS responses to your questions regarding Medicare Advantage plan coverage for VNS treatment for depression since MA coverage is established by standard A/B policy.  Additionally, the 2014/2015 DAB appeal decision attached upheld CMS’ policy. As such, the attached CMS letters are considered comprehensive and fully respond to questions regarding health insurance coverage of VNS for treatment of depression.

I would like to thank your patience and for the opportunity to speak with you and thank you for your advocacy regarding those suffering with depression and VNS therapy.

It was my pleasure to assist you.

Very truly,

Gaetana Marshall

Ms. Gaetana Marshall, M.S.

Health Insurance Specialist

US Department of Health and Human Services

Centers for Medicare and Medicaid Services

Division of Medicare Health Plans Operations

61 Forsyth Street, Suite 4T20

Atlanta,  Georgia  30303

Ofc:  404-562-3562

Fax: 443-380-5963

Email: gaetana.marshall@cms.hhs.gov

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Stolen equipment and the expeditious resolution…

To Joyce’s fellow VNS patients et al,

Just recently we ran into an unusual problem(s). We made an appointment with Joyce’s attending physician to interrogate her VNS prosthesis. The appointment was made for Monday, June 22, 2015. As we were about to leave our home for our scheduled appointment we received a call cancelling the appointment as the doctor could not find his handheld computer to interrogate the device.

We rescheduled the appointment for the following Monday, June 29, 2015 and I advised his office I would send a reminder to the doctor on Sunday prior to our office visit to bring the equipment. I e-mailed the doctor as a reminder early Sunday and later that evening I received a return correspondence that the interrogating equipment had apparently been stolen from his office. Late that same evening I sent an e-mail to Dan Moore, CEO – Cyberonics and his associates asking for help. Much to my surprise even later that Sunday evening I received a reply.

I have been allowed to share the correspondence and events that have unfolded and acknowledge the coordinated efforts of the Cyberonics staff. . I wish to extend my appreciation and gratitude publicly for the expeditious handling and resolution of the problem(s) and help I received. I rightly feel it proper to exhibit all sides of the coin unbiasedly as possible in view of the fact that I have at times respectfully expressed harsh critical opinions of the company as it related to several other issues.

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 11:25 AM
To: Dr. Ely Pelta
Subject: Reminder...

Hi Doc,

Just a friendly reminder to please bring the wand with you to interrogate Joyce’s prosthesis tomorrow!

I hope all is well with you and yours.

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Ely Pelta [Redacted]
Sent: Sunday, June 28, 2015 1:50 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb. The wand went missing, can you provide me with a contact to get a replacement wand?   It most likely was stolen.  I looked everywhere
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 6:14 PM
To: 'Ely Pelta'
Subject: RE: Reminder...

Doc,

Is the wand all that is missing or are you missing the handheld computer too?

Please let me know promptly and I’ll try to contact Dan Moore, CEO of Cyberonics to help us out.  I’ll cancel our appointment for tomorrow until you’re once again equipped.

Thanks,

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Att [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 8:53 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb, missing it all , thanks for understanding
Sent from my iPad

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 9:38 PM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Jackie J. Baumgartner; Dr. Mark Bunker; Bryan Olin, Ph.d
Subject: Stolen equipment...

Dear Dan,

I hope this note finds you and yours all doing well.

I need your assistance.  Apparently someone has stolen Dr. Ely Pelta’s handheld computer and wand and I shall have to cancel Joyce’s appointment for tomorrow to have her prosthesis interrogated.

I would sincerely appreciate if you could have one of your staff immediately contact Dr. Pelta to arrange for a replacement of the equipment.

Dr. Ely Pelta

Miami Beach Community Health Center

11645 Biscayne Boulevard

Miami Beach, FL 33141

305-538-8835 x1670 for Dr. Pelta

(Redacted)

Bianca F., nurse for Dr. Pelta

Carla is Dr. Pelta’s secretary at 305-538-8835 ext. 1670

As always, I thank you for your prompt attention to my concerns as I wish you all well.

Dr. Pelta,

Please have your office notify me promptly once you’ve obtained the replacement equipment so that we may reschedule Joyce’s appointment.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, June 28, 2015 10:40 PM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Jackie J Baumgartner; Mark Bunker
Subject: Re: Stolen equipment...

Dear Herb,
I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.
Best regards,
Bryan
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 10:59 PM
To: 'Bryan Olin'
Cc: 'Dan Moore'; 'Dr. Ely Pelta'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Dear Bryan,

Thank you for your very speedy reply.  It is most appreciated.

We’ll at worst have to reschedule for next week but it is your cooperation and that of your company’s personnel that is most impressive and outstanding to me.

I may have some respectful differences on certain issues with you folks but I cannot deny the fact they y’all have gone to bat through the years to help me care for Joyce for which I truly thank you.

Once again, thanks Bryan.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Ely Pelta [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 11:16 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

Great job Herb !
Sent from my iPhone

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:06 AM
To: fabrik@bellsouth.net
Cc: (Redacted)

Subject: RE: Stolen equipment...

Mr. Stein,

I am the Nurse Case Manager at Cyberonics who works with the Depression patients and their Psychiatrists.  I was asked to communicate with you about replacing Dr. Pelta’s programming equipment.  We will be overnighting the new equipment to Dr. Pelta’s office in Miami today and he should have it tomorrow morning.  I will reach out to both Carla and Bianca to let them know the replacement equipment has been ordered and to ecxpect arrival tomorrow morning.

If you need assistance with anything else, please let me know.

Take care,

Susan

Susan Dotson, L.V.N., Sr. Manager

Case Management Department

Manager for the Carolinas, Lone Star and Southeast Regions

Depression Case Manager

Toll Free:  1-800-332-1375, ext. 7363

Direct Number:  281-228-7363

Direct Fax:  281-853-1315

E-mail:  susan.dotson@cyberonics.com

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, June 29, 2015 10:44 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Jackie J. Baumgartner
Subject: RE: Stolen equipment...

Dear Susan,

Thank you for reaching out and quickly coming to our assistance.  By copy of this e-mail I am alerting Dr. Pelta to expect the replacement equipment tomorrow and to also alert his staff.

Your prompt help and that of your fellow staff members have proven invaluable to maintaining Joyce’s depression free-state these many years.

Once again, thank you.

Dr. Pelta,

Please have Bianca call me as soon as the replacement programming equipment is received so that we may promptly schedule a new appointment for Joyce.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:47 AM
To: Herbert Stein
Cc: Dr. Ely Pelta; Dan Moore; Bryan Olin; Mark Bunker; Jackie J Baumgartner
Subject: RE: Stolen equipment...

Dear Mr. Stein,

You are welcome…always happy to assist.

Take care,

Susan

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From: Ely Pelta [mailto:(Redacted)]
Sent: Monday, June 29, 2015 1:03 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

I will be looking for it tomorrow
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 01, 2015 1:43 PM
To: Dr. Ely Pelta
Subject: Replacement equipment and rescheduling appointment...

Doc,

I haven’t heard from anyone in your office whether or not you received the replacement equipment so that we can reschedule an appointment for Joyce.

Please advise me.

Herb

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Ely Pelta [mailto;(Redacted)]
Sent: Thursday, July 02, 2015 8:27 AM
To: Herbert Stein
Subject: Re: Stolen equipment...

Came today
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 8:46 AM
To: 'Ely Pelta'
Cc: Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Bryan Olin, Ph.d; Daniel Moore, CEO - Cyberonics; Jackie J. Baumgartner; Dr. Mark Bunker
Subject: RE: Stolen equipment...

Doc,

Thanks.  I’ll schedule a new appointment for Joyce.

Susan, Brian et al,

Thank you too for your prompt help and assistance.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 9:00 AM
To: Herbert Stein; 'Ely Pelta'
Cc: Bryan Olin; Dan Moore; Jackie J Baumgartner; Mark Bunker
Subject: RE: Stolen equipment...

Mr. Stein,

I am glad to hear that the equipment was delivered.  Please let me know if you need assistance again.

Take care and have a nice 4^th of July!

Susan

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 9:21 AM
To: 'Susan Dotson'; 'Ely Pelta'
Cc: 'Bryan Olin'; 'Dan Moore'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Susan,

Thanks again and you too have a happy and safe 4^th of July.  And if you don’t mind, family, friends and business associates all call me Herb.

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 10:20 AM
To: Herbert Stein
Subject: RE: Stolen equipment...

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 15, 2015 8:53 AM
To: Dr. Ely Pelta
Subject: Reminder...

Doc,

Joyce has an appointment with you tomorrow.  Please remember to have the interrogation device available.

Thanks,

Herb

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NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: EDP [mailto:(Redacted)]
Sent: Wednesday, July 15, 2015 1:02 PM
To: Herbert Stein
Subject: Re: Reminder...

It's fired up and ready 

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 10:45 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker
Subject: VNS Technical Question

Dear Susan,

Once again I’d like to take this opportunity to thank all you guys for speedily coming to our assistance.

Yesterday we finally got to see Dr. Pelta who interrogated Joyce’s prosthesis (Model 104).  All settings for Joyce were normal with one exception as Joyce continues with her depression free state.  Dr. Pelta’s newest handheld computer did not indicate the battery life as we previously were able to view (Please see photo below).  Is there something wrong with the programming or hardware of the handheld device or whatever?

Would you please advise a solution to this problem?

Thank you as always.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Friday, July 17, 2015 10:51 AM
To: Herbert Stein
Cc: Susan Dotson; Dr. Ely Pelta; Dan Moore; Mark Bunker
Subject: Re: VNS Technical Question

Dear Herb,
I contacted our Clinical Technical Support team and asked them to contact you and Dr. Pelta to answer your question.
Best regards,
Bryan
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 11:02 AM
To: 'Bryan Olin'
Cc: 'Susan Dotson'; 'Dr. Ely Pelta'; 'Dan Moore'; 'Mark Bunker'
Subject: RE: VNS Technical Question

Brian,

As always your exceptionally prompt responses I greatly appreciate.

Have a wonderful weekend.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: Dylan Adams [mailto:Dylan.Adams@cyberonics.com]
Sent: Friday, July 17, 2015 3:47 PM
To: fabrik@bellsouth.net
Subject: Joyce's VNS Device

Hi Herb,

Thank you again for talking with me today. While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.

Best regards,

Dylan Adams

Clinical Engineer

Cyberonics, Inc

100 Cyberonics Blvd.

Houston, Texas 77058

Tel: 1.800.332.1375

Direct: 281.727.2571

Fax: 281.853.2735

www.cyberonics.com

This e-mail message may contain confidential or privileged information, including sensitive patient-related information protected by state and federal laws. If you are not the intended recipient of this message, or an authorized representative of the intended recipient, you are prohibited from reviewing, copying, or distributing this message, its attachments, or any information contained in this message. If you received this message in error, please notify the sender immediately by replying to the message and delete this message from your system.

---

This email has been scanned for email related threats and delivered safely by Mimecast.
For more information please visit http://www.mimecast.com

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 2:40 AM
To: 'Dylan Adams'
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Subject: RE: Joyce's VNS Device

Hi Dylan,

Thank you for the telephone call and email yesterday clarifying the battery status Joyce’s model 104 implant.  At the time of your call I was driving to my doctor as I’ve been under the weather and couldn’t take any notes and therefore I was unable to respond to you until now.  Your prompt response and that of your fellow associates is greatly appreciated in resolving several recent issues expeditiously.

By copy of this communication to Joyce’s attending physician, Dr. Ely Pelta, I shall similarly update him as to your company’s updated programming of his newest handheld computer as it relates to the battery status as you explained it to me and the fact Dr. Pelta has other patient(s) who will similarly need their prosthesis interrogated.

“While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.”

Joyce’s previous model 102R at the same settings was in use closing in on 9 years and because of certain health insurance issues at the time we did not want to take any chances that her battery would deplete.  We previously experimented deactivating her device and within 2 weeks she rapidly declined into a severe depression.  Within about 2 days of reactivation of the prosthesis she was depression free once again and we have not looked back.  Her more recent model 104 was implanted October 2013 so it will be unnecessary to trouble you at this time for a “battery life calculation” but I shall record that terminology and process in my records when I feel the time becomes necessary for replacement.  So thank you for that piece of information too.

Once again, I cannot fully express my appreciation to all you folks for the very prompt and expeditious handling and assistance you all have shared and executed on our behalf.  Most importantly despite Joyce’s other advancing neurological challenge PSP (Progressive Supranuclear Palsy) which would be cause for severe depression Joyce continues in a depression free state for which I am eternally grateful to all who have assisted us in one way or another to give her a reasonable quality of life.  Thank you, thank you and thank you…

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: EDP [mailto:(Redacted)]
Sent: Saturday, July 18, 2015 7:15 AM
To: Herbert Stein
Subject: Re: Joyce's VNS Device

Thank you herb !
Sent from my iPhone

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From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 3:11 AM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Dylan Adams - Clinical Engineer - Cyberonics
Subject: Publicly sharing recent correspondence...

Dear Dan et al,

As you are aware from my recent correspondence with your associates we ran into a couple of issues which were expeditiously resolved by your staff.

I would like your permission to share the correspondence I have recently had between Bryan, Susan and Dylan publicly in what I consider a truly favorable light as to how your organization has functioned expeditiously to help one of its patients and physician.

Putting our differences aside as to the legal issues of the Guarantee and the anti-kickback statutes which I blogged previously I do try to maintain a balanced perspective regarding the VNS Therapy as well as all treatments and I think this is an opportunity for me to favorably blog the good your organization has demonstrated.

Please let me know if this is acceptable to you and your staff.

As always, I wish you all wellness and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Saturday, July 18, 2015 3:56 PM
To: Herbert Stein; Dan Moore
Cc: Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: RE: Publicly sharing recent correspondence...

Dear Herb,

Thank you for the kind words.  We always appreciate the feedback on the level of service we provide-it is great to see Dylan and Susan’s work recognized.  However, please don’t feel any obligation to include this in your blog.  Our perspective is that this is simply the level of service that we owe our patients, caregivers and physicians as a medical device company.

As always, don’t hesitate to contact us with any further questions.

Best regards,

Bryan

///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 11:20 PM
To: 'Bryan Olin'; 'Dan Moore'
Cc: 'Dr. Ely Pelta'; 'Mark Bunker'; 'Susan Dotson'; 'Dylan Adams'
Subject: RE: Publicly sharing recent correspondence...

Hi Bryan,

I don’t feel any obligation but when I undertook some 15 years ago sharing our experiences, my research and collaborations with many of the patients and professionals as it related to VNS Therapy for Depression I did so because Joyce and I were intimately involved with the therapy.  While doing so I felt by sharing with others my accumulated knowledge from the viewpoint of a support person as well as a long-time mental health advocate/activist that it might benefit someone else.  I also endeavored to share both pro and con as well as the good or bad as unbiasedly as possible and where I felt it appropriate to inject my personal opinion(s).

I have also been given permission in many instances through the years to publicly share personal correspondence both from patients and professionals to emphasize both sides of the coin and to establish creditability of the website(s) I established.  Then too, I have also been requested to not publicly share many communications which I have also complied with.  I share Joyce and my personal address information, as you will note, along with my correspondence to help establish our creditability and the fact we have nothing to hide and are real people unlike some other sites, participants and webmasters I have encountered through the years.   

Certainly I have been assertive and outspoken while trying to be respectful about several issues not favorable to Cyberonics while on other matters I have expressed my gratitude and admiration.  I am well aware of patients who have been extremely dissatisfied with both your company and therapy and I have freely shared that information too.  I now have experienced another instance which is both pro and good, in my opinion, and I would like to share that information by presenting the quick action on your part, late on a Sunday evening, and the prompt follow up by your other associates to overcome these two (2) recent issues and I can think of no better way to illustrate those facts than by sharing our various recent communications.

I do appreciate and thankfully acknowledge your taking your valuable time and consideration to address this matter too.

Once again, may I be allowed to publish the recent correspondence I’ve had with you, Susan and Dylan?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, July 19, 2015 11:33 AM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: Re: Publicly sharing recent correspondence...

Dear Herb,
It would be fine if you would like to share the experience in your blog.
Best regards,
Bryan
Sent from my iPhone

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And in the words of the late Paul Harvey and now you have “The Rest of the Story”.

Herb

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

July 13, 2015

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

Posted: Wednesday, July 8, 2015 4:25 pm

TIRR Memorial Hermann is one of three U.S. sites participating in stroke trial

TIRR Memorial Hermann is taking part in a clinical trial aimed at assessing Vagus Nerve Stimulation (VNS) during rehabilitation for improved upper limb motor function following a stroke. According to the American Heart Association, someone in the United States has a stroke every 40 seconds and stroke is a leading cause of disability in the United States.

The goal of this research is to improve and maximize arm and hand function in stroke survivors. The current study is an extension of a clinical trial conducted last year in Europe. Following the European clinical trial, some patients were able to resume daily activities like driving, cooking, and taking care of young children.

TIRR Memorial Hermann is one of only three sites in the United States participating in this trial. Dr. Gerard E. Francisco, chief medical officer at TIRR Memorial Hermann and Professor and Chairman of Physical Medicine and Rehabilitation Department (PM&R) at UT-Health and Dr. Nuray Yozabitran, researcher in the UTHealth Neuromodulation and Neural Interfaces Laboratory at TIRR Memorial Hermann’s NeuroRecovery Research Center are coordinating the Houston trial.

“At TIRR Memorial Hermann we’re known around the world for our rehabilitation services. But the cutting edge research we are doing is important so that we can continue to rehabilitate even better,” says Dr. Francisco. “The results from the European clinical trial were very promising and we’re excited to get our research underway.”

The trial requires an outpatient surgical procedure to place an electrical device in the patient’s chest area. The device is then connected to the vagus nerve in the neck using thin wires that are also implanted.

The vagus nerve directly connects to the brain and sends important signals to tell the brain what to learn. The patient will do a series of therapeutic tasks aimed at rebuilding the neural circuits in the brain that are responsible for upper limb movement. Each time the patient completes a correct movement, the therapist pushes a button and the patient receives a small burst of neurostimulation, which activate the vagus nerve. VNS aims to encourage the growth of new neural connections in the brain that may have been damaged by a stroke.

The treatment uses the Vivistim System developed by Texas based medical device firm MicroTransponder.

To participate in the trial you must be between the ages of 30 and 80 and have had a stroke at least four months ago but not more than five years ago. You must also experience some arm and hand movement difficulties.

To learn more about the trial go to http://www.vnsstroketrial.com/ or call (713) 797-5282.

http://www.fbherald.com/tirr-memorial-hermann-is-one-of-three-u-s-sites/article_77c42680-5f77-5943-9ef5-7480a81b1ada.html