CIT 2018: BIOFLOW-VI confirms non-inferiority of Orsiro to Xience

308
Orsiro

Nine and 12-month data for Orsiro—presented by Yang Yue Jin (Fu-Wai Hospital, National Center of Cardiovascular Disease, Beijing, China) at the China Interventional Therapeutics (CIT) 2018 congress (22–25 March, Suzhou, China)—indicate that the biodegradable polymer stent is non-inferior to an everolimus-eluting permanent polymer stent (Xience, Abbott) in terms of late lumen loss.

According to a press release, BIOFLOW-VI is a prospective multicentre, randomised, controlled clinical trial. The study included 440 patients at 11 study sites in China. Patients with coronary artery disease were randomized 1:1 to receive either the Orsiro (an ultrathin sirolimus-eluting stent) or Xience. The primary endpoint of in-stent late lumen loss was met at nine months: 0.05mm +/-0.21mm vs. 0.07mm +/-0.2 mm, respectively. Target vessel failure remained low and equivalent in the two arms (2.3% vs. 2.3%, respectively). No definite or probable stent thrombosis was observed in either group. These study results support Biotronik’s submission for Orsiro market approval in China.

Yang comments: “Orsiro has been widely proven internationally. With these results, we can confirm Orsiro’s efficacy in a Chinese population. We hope the outcomes of the BIOFLOW-VI study will support making this innovative product available to Chinese patients.”

Gunnar Wochnowski, regional vice president, Biotronik Asia Pacific, notes: “China is one of the most important healthcare markets in the world. These results represent an important milestone for Biotronik. We look forward to making one of our most exciting products available to Chinese physicians and patients soon.”

The press release reports that, used in Europe and around the world, Orsiro has consistently displayed its effectiveness and safety in numerous clinical trials—enrolling a total of more than 32,500 patients. In the BIOFLOW-V trial, a pivotal US investigational device exemption trial, Orsiro demonstrated significantly lower target lesion failure at 12 months compared to Xience.

Nine and 12-month data for Orsiro—presented, by Yang Yue Jin (Fu-Wai Hospital, National Center of Cardiovascular Disease, Beijing, China) at the China Interventional Therapeutics (CIT) 2018 congress (22–25 March, Suzhou, China)—indicate that the biodegradable polymer stent is non-inferior to an everolimus-eluting permanent polymer stent (Xience, Abbott) in terms of late lumen loss.

According to a press release, BIOFLOW-VI is a prospective multicentre, randomised, controlled clinical trial. The study included 440 patients at 11 study sites in China. Patients with coronary artery disease were randomized 1:1 to receive either the Orsiro (an ultrathin sirolimus-eluting stent) or Xience. The primary endpoint of in-stent late lumen loss was met at nine months: 0.05mm +/-0.21mm vs. 0.07mm +/-0.2 mm, respectively. Target vessel failure remained low and equivalent in the two arms (2.3% vs. 2.3%, respectively). No definite or probable stent thrombosis was observed in either group. These study results support Biotronik’s submission for Orsiro market approval in China.

Yang comments: “Orsiro has been widely proven internationally. With these results, we can confirm Orsiro’s efficacy in a Chinese population. We hope the outcomes of the BIOFLOW-VI study will support making this innovative product available to Chinese patients.”

Gunnar Wochnowski, regional vice president, Biotronik Asia Pacific, notes: “China is one of the most important healthcare markets in the world. These results represent an important milestone for Biotronik. We look forward to making one of our most exciting products available to Chinese physicians and patients soon.”

The press release reports that, used in Europe and around the world, Orsiro has consistently displayed its effectiveness and safety in numerous clinical trials—enrolling a total of more than 32,500 patients. In the BIOFLOW-V trial, a pivotal US investigational device exemption trial, Orsiro demonstrated significantly lower target lesion failure at 12 months compared to Xience.

(Visited 174 times, 1 visits today)

LEAVE A REPLY

Please enter your comment!
Please enter your name here