New Kit for VNS
Inc. (NasdaqGS: CYBX
- News), a leading
neuromodulation company, has received approval from the US Food and Drug
Administration (FDA) for AspireHC (High Capacity), a new and improved generator
to be used in vagus nerve stimulation (VNS) therapy.
generation of VNS Therapy. It has longer battery life, more user-friendly
features and improved electronics that proves more beneficial to VNS patients
as well the physicians. This approval will also pave the way for introduction
of new products in future like the AspireSR seizure response system, whose the
European clinical trial is expected by the first half of 2011. Cyberonics plans
to begin the limited launch of AspireHC generator in the first quarter of
fiscal 2011 (ending April 29).
device that stimulates the vagus nerve by sending electrically pulsed signals.
It is specially used for treatment-resistant depression when all other
anti-depressant treatments fail.
device to receive FDA approval for the treatment of epilepsy. The device has
the potential to treat other neurological disorders, such as depression,
Alzheimer’s disease, anxiety, bulimia, fibromyalgia, obesity, obsessive-compulsive
disorder, multiple sclerosis and traumatic brain injury. The device is widely
accepted amongst neurosurgeons, as reflected by the sales of the company. Till
now more than 60,000 patients worldwide have been implanted with the VNS
therapy system for epilepsy and many more have used it for depression.
quarter of fiscal 2011, 17% higher than $40.7 million in the year-ago period.
Sales related to epilepsy units increased 14% in the US and 6% in the
We are encouraged by its improvement in the international business. With the
presence of players such as Medtronic
(NYSE: MDT - News) and St. Jude Medical
(NYSE: STJ - News), the company faces stiff
competition. We are also concerned about the reimbursement related issues faced
currently by the company.