13 WTHRBack fix gets FDA approval

Back fix gets FDA approval

Anne Marie Tiernon/Eyewitness News

Indianapolis - A solution for bulging and herniated discs just got the go-ahead from the Food and Drug Administration.

Before now, you had to be enrolled in a clinical trial to try this surgical solution. But after seven years of study, starting this month, it's now available to everyone.

After a car crash, Kevin Wacausey feared his days on the golf course were over.

"I couldn't turn my head to either side, couldn't raise it back and forth. My left arm was basically useless," he said.

Steroid shots offered no relief, so at 41, Kevin signed up for a new solution in a clinical trial.

"He was the first patient in the country to have an artificial disc in his neck," said Dr. Rick Sasso of the Indiana Spine Group.

Dr. Sasso was the principal investigator for Medtronic's Bryan Cervical Disc.

"This is the only disc that allows normal shock-absorbing characteristics," he said.

The titanium and polyurethane device replaces a diseased or bulging C-3 to C-7 disc.

"So what we do is, we take the disc out," Dr. Sasso said.

That provides more space for a pinched nerve. The traditional solution was a fusion and Wacausey's x-rays show a difference.

"What we really look at is the levels above and below and he has a normal disc above and a normal disc below," Dr. Sasso said. "That is really important, because a lot of time, patients who have fusions have progressive arthritis at those adjacent segments."
 
Patients across the country participated in the study - half got the disc, half got fusion.

"What is interesting is, not only do the artificial disc patients do better in the functional outcome measures, but they have less reoperations than the fusion patients," Dr. Sasso said.

The doctor reported study results to the FDA two years ago and now the device in Wacausey's back received the FDA's approval.

"I think it is a big deal and the reason it is a big deal, it is the best science we have about this very common problem that occurs in our neck," Dr. Sasso said.
 
"They cannot have the disc back. I mean it's mine. There is no way they can have it back, it works too good," Wacausey said.

FDA Approval
Bryan Cervical Disc