Medtronic devices receive FDA, Japanese approvals

By Lisa Kerner

Charlotte, N.C., Sept. 19 - Medtronic, Inc. said the Food and Drug Administration's Orthopedic and Rehabilitation Devices advisory panel unanimously approved its Prestige Cervical Disc System.

The panel's decision will be considered as the FDA reviews the company's Premarket Approval application for the device, designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine.

The Minneapolis-based medical technology company also received Japanese regulatory approval and will begin sales of the Micro-Driver coronary stent system, the first Cobalt-Chromium stent designed for small blood vessels requiring stents smaller than 3 millimeters in diameter.

Cobalt-Chromium is the preferred stent technology in Japan, with more than 75% of the coronary stent market, according to the company.

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