Artificial Spinal Disc Nears Approval
Experts Say More Long-Term Safety Information Needed
Doctor Training Required
These front-approach surgeries carry high risks, including the danger of damaging blood vessels, says David W. Polly, MD, chief of spine surgery at the University of Minnesota. "What I'm concerned about is this is the first [permanently implantable disc] out of the block," he tells WebMD.
"The challenge is going to be how do you rein in surgeons, how do you do it right," says Polly, who is a paid consultant for Medtronic Inc., a rival medical device company. Medtronic is a WebMD sponsor.
The panel also called on the company to provide training for surgeons who want to implant the artificial disc.
William P. Christianson, DePuy's vice president for clinical and regulatory affairs, assures the FDA that his company would set up training centers to educate surgeons on how to implant the device more safely if the FDA approves it.
"Obviously, physician training is going to be very important for successful launch of this product," he says.