Medical Device Daily Senior Staff Writer

Physicians treating patients with refractory epilepsy will soon have another choice of stimulation devices to choose from, as Cyberonics (Houston) continues to develop its vagus nerve stimulation (VNS) therapy technology and offer newer versions of its technology.

Last week Cyberonics said the FDA has approved its AspireHC (high capacity) generator for use in VNS therapy.

The AspireHC generator (development name NXT HC) represents the fifth generation of VNS Therapy device, Dan Moore, Cyberonics' president/CEO told Medical Device Daily, calling it a "continued evolution of our product line." The product incorporates greater functionality for the benefit of patients and their physicians, including longer battery life, improved electronics and simplified features for programming, he noted.

The company expects to launch a limited release of the AspireHC generator in the U.S. in the company's current quarter ending April 29. Cyberonics also has applied for the CE mark.

"The AspireHC generator will enhance the quality of life for VNS patients, and we are gratified that the FDA completed their review in an expeditious manner," Moore said. "In addition, this generator provides an important platform for future new product introductions, including the AspireSR seizure response system for which a European clinical trial is planned to start in the first half of calendar 2011."

The VNS Therapy system consists of an implanted pacemaker-like device about the size of a small pocket watch that delivers mild, intermittently pulsed signals to the patient's left vagus nerve, which then activates various areas of the brain. The original system has been FDA approved since 1997 and is indicated for epilepsy patients at least 12 years old with partial-onset seizures that are refractory to antiepileptic medications.

To date, more than 60,000 patients worldwide have been implanted with the VNS Therapy System for epilepsy, the company noted.

The AspireHC is the same size as the company's third generation product, the pulse product, Moore said. He added that the newest device combines the best of both the company's VNS Therapy pulse and the Demipulse devices with a larger battery and a more efficient use of the battery life, but also better electronics.

While the AspireHC is larger than the Demipulse product, Moore emphasized that it is the same size as the third-generation pulse product. It is not a step backwards towards a larger device, he said.

"The AspireHC will be the platform for the seizure response product that will really represent a new approach for patients with epilepsy," Moore told MDD. He said the previous generation devices are somewhat passive in the sense that they are programmed for continuous intermittent stimulation around the clock. Usually patients with the device receive stimulation for about 30 seconds every five minutes.

Patients with today's pulse and Demipulse products also have a magnet that they can swipe over the device in between stimulations if they sense a seizure coming on. The latest generation device is designed to sense when the patient is heading towards a seizure and initiate a response automatically.

"We won't take the magnet away but it will attempt to automate the magnet mode hardware," Moore said.

"I think it's the natural evolution of the product line but the broader picture is just creating a pipeline of products for patients with epilepsy," Moore said. "We believe that with improved technology we continue to meet the needs of more patients with refractory epilepsy."

The move towards newer generations of the VNS Therapy system is consistent with the company's goal to grow its business and become more of an epilepsy management company, which it reported about a year ago that it wanted to do (Medical Device Daily, Jan. 11, 2010).

Cyberonics' competition includes NeuroPace (Mountain View, California), a company that submitted a PMA application to the FDA last year for its RNS system, a device that uses responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur (MDD, July 29, 2010). NeuroPace has been working on its technology since 2000.

Medtronic (Minneapolis) also has a deep brain stimulation therapy for epilepsy in development. Patients in a completed study of the device reported experiencing a 68% reduction in seizure frequency and some had seizure-free intervals ranging from six months to more than four years (MDD, Dec. 9, 2009).

Amanda Pedersen, 309-351-7774;

amanda.pedersen@ahcmedia.com

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