BIOTRONIK announced today the start of an international study comparing the company's ORSIRO sirolimus-eluting coronary stent with Abbott Laboratory's XIENCE PRIME everolimus-eluting coronary stent. The first implantations in the study, called BIOFLOW-II, took place in Europe last week.
“The exciting addition of the ORSIRO hybrid drug-eluting stent allows us to offer the world's most advanced product portfolio for vascular intervention and paves the way for the drug-eluting absorbable scaffold we are developing.”
Prof. Dr. Michael Haude at Neuss Luke Hospital, Germany, enrolled the first patient. The study is being conducted under the leadership of co-principal investigators Prof. Stephan Windecker of University Hospital Bern, Switzerland, and Dr. Thierry Lefevre of Hospital Jacques Cartier, France.
BIOFLOW-II is a prospective international trial that will randomize approximately 440 patients with ORSIRO or XIENCE PRIME in a two-to-one manner at 19 European sites. The primary endpoint is in-stent late lumen loss at 9 months. Secondary endpoints include clinically driven target lesion revascularization, target vessel revascularization and target lesion failure. Clinical follow-up will take place at 1, 6 and 12 months—and annually out to 5 years.
The ORSIRO hybrid drug-eluting stent (DES) received CE mark approval earlier this year and features the latest development in BIOTRONIK stent technology—a unique hybrid solution that combines passive and active components. PROBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating is layered on the high performance PRO-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and outstanding deliverability.
The initial clinical trial of the ORSIRO DES, called BIOFLOW-I, met its primary endpoint with in-stent late lumen loss at 9 months of 0.05 mm ±0.22 mm. At 9 months, there was no binary restenosis, death, myocardial infraction or stent thrombosis—and only two patients required a repeat procedure.
"BIOTRONIK already offers a strong coronary and peripheral passive device portfolio, and we will continue to introduce innovative technologies, such last year's launch of the Pantera® Lux drug-eluting balloon," said Alain Aimonetti, Vice President Sales and Marketing, Vascular Intervention. "The exciting addition of the ORSIRO hybrid drug-eluting stent allows us to offer the world's most advanced product portfolio for vascular intervention and paves the way for the drug-eluting absorbable scaffold we are developing."
BIOTRONIK is continuing a comprehensive clinical strategy to support the ORSIRO hybrid DES. Enrollment in BIOFLOW-III, a global, open-label registry that will include more than 1,000 patients, will begin later this year.
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