BIOFLOW-IV Data Presented in Japan for Biotronik's Orsiro DES
March 23, 2017—Biotronik announced that 12-month results of the BIOFLOW-IV clinical study of the company's Orsiro hybrid drug-eluting stent (DES) were presented at the 81st annual scientific meeting of the Japan Circulation Society, which was held March 17–19 in Kanazawa, Japan. BIOFLOW-IV is a prospective, multicenter, randomized, controlled trial with a 5-year follow-up.
The company advised that the study's positive results support the submission for Japanese market approval of the Orsiro, which is an investigational device in Japan. The device received European CE Mark approval in 2011.
According to Biotronik, the BIOFLOW-IV study included 579 patients from 12 Japanese sites and 34 sites outside of Japan. Patients with de novo coronary lesions were randomized in a 2:1 ratio to the Orsiro device and the Xience Prime DES (Abbott Vascular). Noninferiority of the primary endpoint of target vessel failure was confirmed at 3.5% in the Orsiro arm and 4.2% in the Xience Prime arm at the 12-month mark (P = .0001).
In the company's press release, Shigeru Saito, MD, the study's coordinating clinical investigator, commented, "In the BIOFLOW-IV study, the excellent efficacy and safety profiles of Orsiro was confirmed. This outcome is consistent with the outcomes of other Orsiro clinical studies. I look forward to seeing Orsiro obtain premarket approval from the Japanese government and being made available to Japanese patients." Dr. Saito is Director of Cardiology and Catheterization Laboratories, and Vice President at the Shonan Kamakura Hospital in Kanagawa, Japan.