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FDA Issues Non-Approvable Letter for Medtronic's Amplify BY SANDER DUNCAN, MARCH 11, 2011

Medtronic disclosed in its 10-Q on Wednesday that the FDA issued a non-approvable letter for Amplify, its new BMP-2 product. Last July, amid concerns of a higher incidence of cancer in patients treated with Amplify, an FDA advisory panel narrowly voted in favor of approving the product. In the 6-5 vote, which included 3 abstentions, the panel asserted that Amplify's benefits outweigh its risks. This week's non-approvable letter is unusual in that the FDA typically makes its final decision in line with the panel's recommendation.

Medtronic and its peers have a turbulent history with BMP products. The company currently sells the FDA-approved BMP product Infuse for indications including open tibial fractures and certain ALIF procedures. However, an estimated 85% of BMP use is off-label, and complications have arisen from its off-label use. Last September, a MEDCAC panel expressed low confidence in BMP's off-label applications, increasing the risk of reimbursement restrictions. Meanwhile, Stryker's BMP product, OP-1, was likewise given a vote of low confidence by the MEDCAC panel based on a dearth of evidence regarding its clinical benefits.

Medtronic was seeking a postero-lateral fusion indication for Amplify, for which Infuse is already widely-used off-label.

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