FDAnews Device Daily Bulletin

Biotronik's Coronary Stent System Wins FDA Approval

Feb. 17, 2017

The pro-kinetic energy cobalt chromium coronary stent system produced by Biotronik has gained FDA marketing approval.

The device is designed to expand coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries.

The ultra-thin stent allows for deliverability under the most extreme conditions of bending and calcification.

It is indicated for patients with a blockage in arterial vessels between 2.25 and 4.0 mm in diameter and lesion lengths up to 31 mm. — Cynthia Jessup

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