In “Fantastic Voyage” (April), we tracked the tumultuous story of Houston-based Cyberonics Inc., a medical-device company that had developed a new kind of pacemaker that helps patients with epilepsy. Back then, Cyberonics was hoping to win another approval from the Food and Drug Administration to sell its device to patients who suffer from severe, drug-resistant depression, a huge potential market.
But things at Cyberonics are still tumultuous. On June 15, an FDA advisory panel gave the thumbs-up to use Cyberonics’ device for depression. While the FDA usually listens to these expert boards, it rejected the panel’s advice in August, refusing to approve the Cyberonics stimulator for depression. (In some patients, depression had gotten worse, and the company was criticized for running a poorly designed clinical trial.) One analyst called it a “devastating blow.” Cyberonics chairman and chief executive Skip Cummins turned down our request for an interview, but said in a statement that the company had two options: Appeal the FDA’s decision or conduct another expensive clinical trial.
As part of the same story, we followed the surgery of 6-year-old Jordyn Cook, who was having the Cyberonics device implanted to help her epilepsy. After the piece ran, dozens of readers emailed asking for an update on Jordyn’s condition.
Jordyn’s father, Peter Cook, says the implant hasn’t eradicated Jordyn’s seizures. “It’s not a success yet,” he says. “She had five seizures last week.” But sometimes, activating the device when Jordyn thinks a seizure is on the way seems to stave it off. “We’re hoping that all of a sudden it will click,” he says. “We’re reserving judgment.” This fall, Jordyn started the first grade in Kingston, Massachusetts.FCS