Biotronik announced today that the FDA has approved its bare-metal stent for improving the coronary luminal diameter in patients with de novo or recurrent coronary artery occlusions.
The cobalt-chromium stent (Pro-Kinetic Energy) has ultrathin struts of 60 µm, enabling deliverability in even extremely calcified or tortuous arteries, according to a press release from Biotronik.
The BMS is indicated for patients with occlusions in arterial vessels between 2.25 mm and 4 mm in diameter with lesion lengths 31 mm, according to the release.
The company stated that approval was based on results from the global BIOHELIX-I study of 329 patients, in which the BMS was associated with a target vessel failure rate of 9.06% at 9 months, beating the performance goal of 18.7%. In addition, according to the release, in the ENERGY registry, at 12 months the BMS conferred an 8.1% rate of MACE and a 4.9% rate of target lesion revascularization.
According to the release, the BMS is Biotronik’s first coronary stent approved for the U.S. market.