CYBERONICS CONFIRMS SAFETY AND EFFICACY OF VNS THERAPY®

From: Jackie Baumgartner [mailto:corporate_intelligence@broadcast.shareholder.com]

Sent: Friday, November 05, 2010 12:35 PM

To: (Redacted)
Subject: CYBERONICS CONFIRMS SAFETY AND EFFICACY OF VNS THERAPY®

 For Immediate Release Friday, November 5, 2010

CYBERONICS CONFIRMS SAFETY AND EFFICACY OF VNS THERAPY^®

 

HOUSTON, Texas, November 5, 2010 -- To correct and clarify assertions and implications included in some recent media reports, Cyberonics, Inc. (NASDAQ:CYBX) today confirmed the safety and efficacy of its vagus nerve stimulation (VNS) Therapy by emphasizing that VNS Therapy is an important treatment option for patients with epilepsy who have tried and failed multiple medications and for whom brain surgery is not an option. Approximately 60,000 patients have been implanted with VNS Therapy worldwide over the past 16 years.

The company noted that uncontrolled epilepsy is life-threatening and puts patients at increased risk for accidental death and sudden unexpected death from epilepsy (SUDEP). VNS Therapy, in combination with epilepsy medication, provides a safe and effective means of combating drug-resistant epilepsy for these patients. 

Specific to the incorrect and misleading media assertions, Cyberonics stated that:

-      It is not aware of any death of an epilepsy or depression patient caused by VNS Therapy.

          In seven pre-approval clinical studies involving more than 700 patients and two post-approval clinical studies involving more than 300 additional patients, it collected, analyzed, and submitted morbidity and mortality data to the U.S. Food and Drug Administration (FDA).

Available data demonstrate that all-cause mortality rates for VNS Therapy patients with epilepsy are less than half the rates in the comparable non-VNS epilepsy patient population (6.8 vs 14-19 per 1,000 patient years). Additionally, the rates of SUDEP for VNS Therapy patients are less than half the rates in the comparable non-VNS epilepsy patient population (4.1 vs 9.3 per 1,000 patient years).

·        Safety and efficacy is clearly demonstrated in both pre-approval epilepsy studies as well as longer-term follow-up studies:

–         Pre-approval epilepsy studies included two randomized controlled clinical studies in which 23%-30% of patients experienced a reduction in seizure frequency by at least half.

–         Subsequent studies showed that 40%-60% of patients may achieve comparable levels of response.

–         The benefits of VNS Therapy are further reinforced by the 70% of patients who choose to have their generator replaced when the battery is depleted.

Cyberonics concluded by noting its long tenure as a leader in the field of devices for epilepsy, and that it is proud of its proven record of helping to improve the lives of patients with epilepsy.

About Cyberonics, Inc. and VNS Therapy^®

Cyberonics, Inc. (NASDAQ:CYBX) is a medical technology company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers electrical pulsed signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics and VNS Therapy is available at www.cyberonics.com.

Contact Information

Michael Geczi (Media Contact)

Financial Dynamics

227 West Monroe

Street, Suite 900

Chicago, IL 60606

Office : (312) 553-6735

michael.geczi@fd.com

Greg Browne, CFO

(Financial Contact)

Cyberonics, Inc.

100 Cyberonics Blvd.

Houston, TX 77058

Main: (281) 228-7262

Fax: (281) 218-9332

ir@cyberonics.com

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Cyberonics, Inc.

100 Cyberonics Blvd.

Houston, TX 77058-2017

 US

November 03, 2010

FDA Failing to Monitor Safety of Medical Devices: Report

TUESDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is not doing its job of properly monitoring the safety of medical devices, the authors of a new report charge.
The FDA has the authority to approve both drugs and medical devices, but the investigators believe that the division responsible for device approval and safety is lax in both its initial approval of devices and its ongoing monitoring of related problems.
"The agency often misses problematic devices," contends lead author Shannon Brownlee, an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.
The report is published in the Nov. 3 online edition of the BMJ.
In their article, Brownlee and New York-based medical investigative journalist Jeanne Lenzer focus on the FDA's approval and follow-up of a device that prevents or reduces seizures in patients with epilepsy who don't respond to drug treatment.
This apparatus, called a vagus nerve stimulator (VNS) is made by Texas-based Cyberonics. The VNS, which is implanted under the skin, works by sending electrical impulses to stimulate the vagus nerve in the neck.
The FDA approved the device in 1997 and some 60,000 patients around the world are using it, according to the manufacturer. In 2005, the FDA also okayed the device as a treatment for medication-resistant depression. There are some 5,000 people who use VNS to treat depression, Cyberonics says.
Brownlee and Lenzer's concern: That during the 13 years the device has been on the market there have been 900 FDA-reported deaths of people using the device to control their epilepsy.
The question of whether any of these deaths were due to the device remains unanswered, however, even though Cyberonics did conduct the post-marketing study the FDA requested at the time of approval.  However, the FDA did not require the study to report the cause of death for individuals using the device, Brownlee and Lenzer said.
FDA spokeswoman Karen Riley said the agency is engaged in an ongoing effort to improve overall medical device safety monitoring. "We have an initiative underway to strengthen post-market monitoring," she said.
But Brownlee believes the story of the VNS device to be just one example of the FDA's failure to monitor the safety of medical devices before and after they are out in the marketplace. For example, she pointed out that less than one-third of devices approved under FDA's pre-market approval process had ever been evaluated in a randomized trial.
And she said that it was physicians, not the FDA, who spotted serious problems with certain implanted defibrillators, for example.  "It was physicians keeping their own database that alerted the company to the problem," Brownlee said.
Moreover, she believes  the agency is not capable of detecting potentially unsafe devices through its own harms database. Brownlee cited a finding that many post-approval studies are either not done, or conducted so poorly "as to be meaningless."
According to the BMJ, the FDA referred Brownlee and Lenzer to five post-approval studies that they said established the device's safety. However, Brownlee said these studies do not prove the device was not the cause of deaths, since none contained mortality data.
Brownlee also said that when the device was approved for depression it was over the objection of FDA's own panel of scientists. And, according to Brownlee, the company has suggested that VNS may be useful for a wide range of other ailments, including  obesity, stroke and traumatic brain injury, and has patented the device for these potential therapies.
According to Brownlee, the FDA will only improve when it gets more staff, better funding, more authority and more outside experts to objectively evaluate device safety.
The new findings come on the heels of a recent embarrassment for the agency: In October, the FDA apologized for mistakenly approving the Menaflex knee implant over objections from its own scientists. In its announcement, the FDA admitted it caved to political pressure from New Jersey senators and a congressman. The FDA has now taken steps to rescind that approval.
"I have sympathy for the FDA, which is understaffed and underfunded in many areas," Brownlee said. "But there is no question that this agency had been captured by the very industries that it is supposed to regulate," she said.
Defending the VNS, Cyberonics chief financial officer Greg Browne said that "none of the approximately 900 deaths reported to the FDA were attributed to VNS therapy."
"Available data demonstrate that all-cause mortality rates for VNS therapy patients are less than half the rates in the comparable non-VNS epilepsy patient population," he added.
Dr. Jerry Avorn, professor of medicine at Harvard Medical School and author of an accompanying journal editorial, agreed with the article's authors that, "until recently the part of FDA that approves devices has been run in a much more loose manner than the part of FDA that approves drugs."
While the FDA has started to deal with some of these problems, "it's still more of a wild west environment than the drug side of FDA," he added.
The agency needs to look harder at the standards it uses when approving new devices, and should revamp its surveillance systems to spot people who have received faulty devices, he added.
"All government regulation is not a bad thing," Avorn said. "It can sometime be life-saving," he said.
More information
For more information on the FDA and medical devices, visit the U.S. Food and Drug Administration.

SOURCES: Shannon Brownlee,  M.S., instructor, Dartmouth Institute for Health Policy and Clinical Practice, Hanover, NH; Jerry Avorn, M.D., professor of medicine, Harvard Medical School, Boston; Karen Riley,spokeswoman, U.S. Food and Drug Administration; Greg Browne, chief financial officer, Cyberonics; Nov. 3, 2010, BMJ, online

http://womenshealth.gov/news/english/645335.htm

Rev Esp Anestesiol Reanim. 2010 Aug-Sep;57(7):431-8.

[Perioperative considerations in vagal nerve stimulator implantation].

[Article in Spanish]

Iturri Clavero F, González Uriarte A, Tamayo Medel G, Pomposo Gaztelu IC, Cano Dorronsoro M, Martínez Ruiz A.

Servicio de Anestesiología y Reanimación, Hospital de Cruces, Baracaldo,. Bizkaia. fib96@euskalnet.net

Abstract

Vagal nerve stimulation has become an a important tool in the treatment of refractory epilepsy, which continues to be the main indication for this technique. Other therapeutic indications are emerging, however, and vagal nerve stimulation has now been approved for major depression. Additional possible uses under study include morbid obesity, Alzheimer disease, chronic pain syndromes, and certain neuropsychologic disorders. This review considers perioperative aspects relevant to using this therapeutic procedure with a view to facilitating better and more integrated management of its application.

PMID: 20857639 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/20857639

Seizure. 2010 Oct 27. [Epub ahead of print]

Efficacy and tolerability of long-term treatment with vagus nerve stimulation in adolescents and adults with refractory epilepsy and learning disabilities.

Lund C, Kostov H, Blomskjøld B, Nakken KO.

National Centre for Epilepsy, Division of Clinical Neuroscience, Oslo University Hospital, Oslo, Norway.

Abstract

The long-term effects of vagus nerve stimulation (VNS) on seizure frequency were studied in 50 patients with epilepsy and learning disabilities. Mean observation time was 4.6 years. At follow-up, none of the patients was seizure-free, 25% had more than 50% seizure reduction, and 46% had some seizure reduction, but less than 50%. The discontinuation rate was 18%. Our results indicate that, like antiepileptic drugs, VNS does not have such a good seizure-reducing effect in patients with epilepsy and learning disabilities compared with the general epilepsy population.
Copyright © 2010 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

PMID: 21035358 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/21035358

Childs Nerv Syst. 2010 Oct 31. [Epub ahead of print]

Vagus nerve stimulation: effectiveness and tolerability in patients with epileptic encephalopathies.

Cersósimo RO, Bartuluchi M, De Los Santos C, Bonvehi I, Pomata H, Caraballo RH.

Neurology Department, Hospital de Niños "Prof. Dr. Juan P Garrahan", Combate de los Pozos 1881, Buenos Aires, CP 1245, Argentina.

Abstract

PURPOSE: We discuss the effectiveness, tolerability, and safety of vagus nerve stimulation (VNS) as adjunctive therapy in 26 patients with refractory epileptic encephalopathies (EEs).
MATERIAL AND METHODS: Twenty-six patients (17 male and 9 female) with electroclinical features compatible with Lennox-Gastaut syndrome (LGS) in 20 patients, Dravet syndrome (DS) in 3 patients, and epilepsy with myoclonic-astatic seizures (EMAS) in 3 patients implanted with the NCP system were analyzed.
RESULTS: In our series of patients with LGS, 17 cases showed a significant improvement in seizure control, with a reduction in seizure frequency of at least 50%. Seven of them previously had epileptic spasms. Three patients with EMAS and two patients with DS showed a significant improvement in seizure control, with a reduction in seizure frequency of at least 50%. A good clinical response was evident early and efficacy progressively improved with the duration of treatment up to 36 months. In patients who had a reduction in seizure frequency of at least 50%, quality of life (QOL) and neuropsychological performance improved. VNS was well-tolerated in all patients.
CONCLUSION: VNS is an effective and well-tolerated treatment for patients with epileptic encephalopathies EEs, improving QOL and neuropsychological performance.

PMID: 21038079 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/21038079

Vagus nerve stimulation effective for focal motor seizures and focal interictal parkinsonian symptoms - A case report

http://www.springerlink.com/content/n08p667x2881j810/

Eur Heart J. 2010 Oct 28. [Epub ahead of print]

Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.

De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; for the CardioFit Multicenter Trial Investigators.

Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Abstract

Aims In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular (LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy. Methods and results This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. Conclusions This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.

PMID: 21030409 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/21030409