FDA News

BMS approved for improvement of coronary luminal diameter

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.

 

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.