Medtronic Inc., a world leader in medical technology, has won a U.S. advisory panel's support for a second artificial neck disc, the Byran cervical disc. This builds upon Medtronic's success with its LandmarX® Element ENT Image Guidance System (IGS), which was recently given a 2007 Medical Device Excellence Award (MDEA) Silver Award.

The Byran cervical disc is a cylindrical capsule with a dense polymer core and titanium end plates to aid those who need multiple disc replacement. It is more similar to a natural spinal disc than Medtronic's first device, called Prestige, which was approved July 16, 2007. The 7-1 vote for approval of the Byran from the Food and Drug Administration (the vote was first announced in May -- see DOTmed's coverage here) confirmed the growing utilization of this technology in the upper spine, where medical professionals feel it will be more successful than lower spine replacements.

The artificial discs are billed as alternatives to spinal fusion because they allow the neck to bend, while the fusion procedure restricts the neck's movement. Dr. Rick Sasso, an Indiana spine surgeon told the panel that patients treated with the Bryan disc "experience exceptional pain relief with the maintenance of their cervical motion."
Artificial cervical disks like Bryan and Prestige can relieve conditions like numbness in the arms or pain associated with degeneration of the discs in the upper spine. Patients receiving the discs may recover faster than those who opt for fusion and regain more neck flexibility.

"We wanted to place our bets in more than one area," said Peter L. Wehrly, president of Medtronic's spinal and biologics group, when asked why the company had invested in two different cervical disk designs.

The estimated number of upper spine fusions performed annually in the U.S. is as high as 250,000. The FDA advisory panel said a Medtronic study following patients for two years showed that the Bryan disc for the cervical spine worked just as well as spinal fusion, successful in 80.6% of the patients.

However, panelists did urge the need for extra evaluation after the approval to follow the implant's long-term performance. Medtronic said the Bryan device proved superior to spinal fusion, but panel members said the company's results were not strong enough to support that claim.

In the midst of these successes, Medtronic is addressing problems in other areas of its medical device business. The Food and Drug Administration recently sent a warning letter to Medtronic regarding safety reporting and monitoring violations in the Minneapolis factory where they make implantable pumps to control pain.

The letter was similar to the one they received last year because of manufacturing violations. The agency also mentioned Medtronic's failure to follow up on at least 37 reports from doctors, patients or their families who had undergone injuries due to problems with the pumps.

Medtronic said it was working with the agency on both of these warning letters. "I am quite sure this device is safe and effective, with the caveat of up to two years," said Kathleen Propert, a panel member and University of Pennsylvania statistician.

But, doubters hold, physicians might not be eager to turn patients away from fusion because of its high success rate and good insurance coverage. Yet cervical disc implantation may cost patients or insurers about as much as fusion surgery. Medtronic spokesman Bert Kelly said the price of both devices will be similar to fusion surgery, which costs about $32,000 to $34,000.

Although Wall Street expects slow expansion of profits due to the caution taken by surgeons and insurers, some analysts believe it could eventually exceed $1 billion.

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