FDA Approves Biotronik's PRO | 合法醫療器材資訊網

February15,2017—ThePRO-KineticEnergyCobaltChromium(CoCr)CoronaryStentSystemfromBiotronikhasgainedU.S.FoodandDrugAdministration ...

February 15, 2017 — The PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from Biotronik has gained U.S. Food and Drug Administration (FDA) approval utilizing results from the BIOHELIX-I clinical study. This stent[1], which has already been used to treat more than 650,000 patients worldwide, is now available in the United States.

The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent[2] is designed to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries. The ultra-thin, 60 µm strut thickness of the stent allows for optimal deliverability under the most extreme conditions of tortuosity and calcification. It is indicated for patients who have a blockage in arterial vessels between 2.25 and 4 mm in diameter and lesion lengths up to 31 mm.

The prospective, non-randomized, multi-center BIOHELIX–I trial evaluated the PRO-Kine...