Epilepsy Device Pioneer Cyberonics Still Evolving After 25 Years
Long before the explosion in the personal electronics field brought us iPods and iPhones, biomedical engineers were making devices to interact with the personal electrical “circuitry” that regulates the human heart and other organs. Back in 1958, Minneapolis, MN-based Medtronic produced its first battery-operated, portable pacemaker to stimulate nerves in the malfunctioning heart. It looked something like an old Sony Walkman cassette player strapped around the waist.
In 1987, Texas entrepreneurs founded a company to try a nerve stimulation device as a treatment for epilepsy. The units now marketed by that company, Houston, TX-based Cyberonics (NASDAQ: CYBX) still have the same basic design: a surgeon implants a unit called a generator under the skin of the upper chest, then threads an electrode from the generator up through the side of the neck. The thin wire, wrapped around the vagus nerve, delivers mild electrical pulses designed to head off seizures. The device is supposed to reduce the frequency of epileptic seizures.
The size of Cyberonics’ generator unit, however, has changed since the first model was approved by the FDA in 1997.
Cyberonics CEO Daniel Moore keeps one of the company’s first models on his desk.
“People say it was the size of a hockey puck,” Moore says. “It wasn’t quite that big.”
Recent improvements in battery technology have allowed Cyberonics to shrink the devices it sells today to the size of a watch face, Moore says. And, like pacemaker manufacturers, Cyberonics has been working to make its Vagus Nerve Stimulation (VNS) Therapy system more responsive to individual needs. The company is also tapping the interactive potential of the units as collectors of data for patients and their physicians.
The latest round of technical improvements come as Cyberonics has largely recovered from a big setback a few years ago. The company hit a low point in May 2007, when Medicare said there wasn’t enough evidence to support use of the Cyberonics device for patients with treatment-resistant depression. The company saw its sales drop 8 percent the following year, before it regained its momentum in 2009, with renewed focus on epilepsy. Sales climbed about 15 percent last year to $218.5 million.
The Texas firm faced no clear competitors when it began developing its implantable units for epilepsy in the 1980s. It was a different situation than the one faced by Medtronic in 1958. Back then, the Minneapolis company’s portable, external cardiac pacemaker helped heat up a race to market the first pacemaker that could be implanted in the body—which Medtronic (NYSE: MDT) did in 1960.
The first task for Cyberonics was to persuade doctors and the FDA that its implantable VNS device had a place in the epilepsy treatment spectrum.
In the United States, nearly 3 million people have epilepsy, according to the Epilepsy Foundation, a non-profit patient support group. About half of those diagnosed can get seizure relief from the first drug prescribed, Moore says. If not, doctors try one medicine after another, alone or in combinations, to find a regimen that works. For two-thirds of patients, drugs will … Next Page »