China Interventional Therapeutics 2018: Orsiro Drug-Eluting Stent Reaches Endpoints in BIOFLOW-VI Study
Orsiro’s Non-Inferiority Shown with Late Lumen Loss of 0.05 mm in Orsiro vs. 0.07 mm in Xience at 9 Months
Dr. Yang Yue Jin, Professor of Cardiology at the Fu-Wai Hospital, National Center of Cardiovascular Disease, Beijing, China, presented the 9- and 12-month results of the BIOFLOW-VI clinical study at the China Interventional Therapeutics (CIT) 2018 congress.
BIOFLOW-VI is a prospective multi-center, randomized, 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 Orsiro1 ultrathin sirolimus eluting stent or the Xience2 everolimus eluting stent. The primary endpoint of in-stent late lumen loss was met at 9 months: 0.05 mm +/-0.21 mm in Orsiro vs. 0.07 mm +/-0.22 mm in Xience.3 Target vessel failure remained low and equivalent in the two arms (2.3% vs. 2.3%). No definite or probable stent thrombosis was observed in either group. These study results support BIOTRONIK’s submission for Orsiro market approval in China.
“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,” commented principal investigator Dr. Yang.
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.4
“Today, 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,” stated Gunnar Wochnowski, Regional Vice President, BIOTRONIK Asia Pacific.
Orsiro is an ultrathin 60 micron5 drug-eluting stent that combines a passive coating and bioresorbable polymer.
1 CAUTION – investigational device in the United States. Limited by US law to investigational use.
2 Xience is a registered trademark of Abbott Cardiovascular Systems.
3 BIOFLOW VI: BIOTRONIK Safety and Clinical Performance of the Drug-Eluting OrsiroStent in the Treatment of Subjects with de Novo Coronary Artery Lesions. Presented at: CIT 2018; March 23, 2018; Su Zhou, China.
4 Kandzari D. et al. Lancet. 2017, 390(10097).
5 Ø 2.25 – 3.0 mm.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.