Medtronic discs OK'd by FDA experts

First-ever artificial neck disc approved for U.S. market; FDA experts also support Medtronic's second disc.

By Aaron Smith, staff writer

NEW YORK ( -- A panel of FDA experts recommended the approval of an artificial spine disc from Medtronic on Tuesday, one day after the agency granted market approval to another one of the company's neck discs.

A panel of experts for the Food and Drug Administration voted 7-1 to give the green light for Minneapolis-based Medtronic's (down $0.32 to $52.14, Charts, Fortune 500) Bryan disc, with certain conditions, said agency spokeswoman Karen Riley.

The Bryan disc, made of titanium and polyurethane, is designed to replace diseased vertebrae in the cervical, or upper, part of the spine.

The panel vote is non-binding. The FDA will take this vote into consideration when it completes its review at a later date.

On Monday, Medtronic said the FDA approved its Prestige disc, making it the first-ever artificial spinal disc approved for the U.S. market. This disc, already available in Europe, is made of stainless steel.

Spinal devices - like lumbar discs for the lower portion of the spine - accounted for $2.5 billion of Medtronic's FY 2007 sales. Pacemakers and defibrillators make up the largest part of the company's business, with $4.9 billion in sales for the year.

Medtronic is also a large manufacturer of cardiovascular stents, competing with Johnson & Johnson (Charts, Fortune 500), Boston Scientific (Charts, Fortune 500) and Abbott Laboratories (Charts, Fortune 500).

Jason Wittes, analyst for Leerink Swann, said in a recent interview that sales for the Bryan and Prestige discs could eventually reach $1 billion, but it would take years to attain that level.

Medtronic's chief competitor for its spinal discs is the more traditional surgical method called spinal fusion, which is used to repair vertebrae. One of the concerns presented by the FDA panelists was that Medtronic's "claims of superiority were inconclusive" when compared to spinal fusion, said Riley of the FDA.

Also on Tuesday, the FDA sent Medtronic a warning letter about quality issues at a Minneapolis factory that makes implantable devices for drug infusion and nerve stimulation, according to Reuters.  Top of page