FDA Approves Abbott’s Xience Prime Drug-Eluting Stent

November 2nd, 2011

FDA Approves Abbott’s Xience Prime Drug-Eluting Stent

Larry Husten, PHD

Abbott announced on Tuesday that it had received FDA approval for its Xience Prime everolimus-eluting stent. The cobalt chromium stent is designed to be delivered more easily to complex lesions and will be available in long lengths up to 38 mm. Approval of Xience Prime was based on the SPIRIT Prime clinical trial, an open-label registry trial of 500 patients. According to the company, the trial reached its primary endpoint and demonstrated at 1 year low rates of target lesion failure and stent thrombosis. Full results of the trial will be presented on November 8 at the TCT (Transcatheter Cardiovascular Therapeutics) meeting in San Francisco.

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November 2nd, 2011