January 21, 2018
Biotronik's Orsiro Coronary DES Approved in Japan
January 22, 2018—Biotronik announced market approval for its Orsiro coronary drug-eluting stent (DES) by the Japanese Ministry of Health. The Orsiro DES features ultra-thin 60-µm struts (≤ 3 mm in diameter) and the company's ProBio coating, which reduces nickel ion release, according to the company.
The approval was supported by the 12-month outcomes of the BIOFLOW-IV clinical study, which is a prospective multicenter, international, randomized controlled trial with 5-year follow-up. The 12-month data were presented in March 2017 at the 81st Japan Circulation Society congress.
According to the company, other recent data on the Orsiro DES were announced in August 2017. The BIOFLOW-V randomized trial was presented at the European Society of Cardiology's ESC Congress 2017 in Barcelona, Spain, and published by David E. Kandzari, MD, et al in The Lancet (2017;390:1843–1852). BIOFLOW-V compared the Orsiro DES and the Xience DES (Abbott Vascular) for the primary endpoint of noninferiority in 12-month target lesion failure.
BIOFLOW-V, a pivotal United States investigational device exemption trial of the Orsiro DES, included a large, complex patient population and was designed in collaboration with the US Food and Drug Administration to support an upcoming premarket approval submission. In the United States, Orsiro is an investigational device limited by law to investigational use only. The Orsiro DES has received European CE Mark approval in 2011 and is commercially available in more than 100 countries.