Biotronik said it launched a U.S. investigational device exemption trial of its Orsiro hybrid drug-eluting stent, the Bioflow-V study.
The Orsiro device’s coating includes 2 components, according to Biotronik: a passive element called ProBio designed to encapsulate the stent to minimize interaction between it and surrounding tissue, and an active combination of a limus anti-restenosis drug and a bioabsorbable polymer.
Bioflow-V, slated to enroll 1,334 patients, is designed to compare the Orsiro device with “another currently marketed DES,” Biotronik said. The prospective, international, multi-center, randomized, controlled study’s primary endpoint is target lesion failure at 12 months, the Berlin- and Oswego Lake, Ore.-based company said.
Orsiro won CE Mark approval in the European Union in 2011. Biotronik said previous studies have shown the stent to be non-inferior to Abbott‘s (NYSE:ABT) Xience stents “in a patient population reflective of routine clinical practice” and noninferior to Terumo‘s (TYO:4543) Nobori device “in a large, all-comers population.”
“Based on the encouraging previous study results, I am very excited that enrollment in the Bioflow-V study has started and Biotronik can begin the process of bringing this remarkable product to U.S. patients,” U.S. principal investigator Dr. David Kandzari, of Atlanta’s Piedmont Heart Institute, said in prepared remarks. “As a treatment option, I have no doubt Orsiro will benefit both patients and physicians in the U.S. as it has for the past 4 years in Europe.”
“Our mission is to improve and save patients’ lives with innovative devices such as the Orsiro hybrid DES,” added Biotronik vascular intervention president Dr. Daniel Bühler. “It is one of our most successful products globally and deservedly holds a place in the Biotronik Masterpieces portfolio. With physicians relying on top-performing tools for each and every procedure, we are very happy to move one step closer to delivering Orsiro to patients in the U.S.”