Senator questions Cyberonics device approval
The Cyberonics product, called the Vagus Nerve Stimulation (VNS) Therapy System, is a stopwatch-sized device that is implanted into the chest and delivers electrical pulses to the brain.
The FDA approved it in July 2005 for treating adults with depression that had not responded to other therapies.
FDA spokeswoman Julie Zawisza said the agency had not seen Grassley’s remarks. She said it was not unusual for an official at Schultz’s level to overrule staff recommendations.The Cyberonics device was approved after the company provided the FDA with additional information showing it could help patients with no other treatment options, she said.
I have personal experience with this Cybernetics outfit. A close family member was fitted with this implant, but it was a defective unit which caused the patient prolonged suffering of electrical shock. This persistent shock was bad enough to induce infection and within six months of receiving the implant the patients body rejected the device. Right through the skin of her chest.
Like a giant zit!
But the device itself is yet another example of an implanted computer device. And this one is intended to actually change the way the patient’s brain functions.
No … we did NOT sue. The procedure was experimental, and we knew that. But we could have sued, and probably would have made a bundle to boot! But don’t get me started on Medical Malpractice reform…
The senator should just shut up!
Since he was ok with voting to rush HIV/AIDS drugs to approval. Why does he choose to pick on the mentally and psychiatrically challenged?
Ok that’s a trick question … the mentally and psychiatrically challenged won’t show up on the steps of the capital wearing g-strings, carrying protest signs, and throwing condoms to that other crowd that will be there … the crowd of reporters.