Paris, France, May 18, 2011 – Final first-in man (FIM) results from the BIOFLOW-I trial on the use of the Orsiro Hybrid Drug-Eluting Stent (DES) were presented today in a late-breaking clinical trials session at the EuroPCR congress in Paris by the clinical coordinating investigator, Prof. Martial Hamon of University Hospital of Caen, France.
The Orsiro Hybrid DES, which features the latest development in BIOTRONIK stent technology, is 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.
Orsiro is based on the leading PRO-Kinetic Energy bare metal stent platform, renowned as the best performing because of its advanced thin-strut stent design and outstanding deliverability.
BIOFLOW-I was a prospective, multicenter, nonrandomized FIM trial enrolling 30 patients. The objective of the study was to assess the safety and clinical performance of the Orsiro Hybrid DES as measured by freedom from major adverse cardiac events (MACE) and in-stent late lumen loss at 9 months, evaluated by quantitative coronary angiography (QCA). At 9 months, the results for the primary endpoint in-stent late lumen loss were 0.05 ±0.22 mm. Two patients were symptomatic at 9 months, resulting in two cases of clinically driven target vessel revascularization (TVR) (6.7%). Clinical follow-up will continue annually out to at least 3 years.
Orsiro demonstrated sustained safety out to 9 months, as indicated by absence of death, stent thrombosis and myocardial infarction (MI).
“The results are especially encouraging considering the challenging patient characteristics, atypical for a FIM trial—a medical history including 73% previous MI and 23% diabetic patients,” commented Prof. Hamon. “The exceptional deliverability of Orsiro is a necessity with the degree of complex stenting that is performed in current cath lab practice.”
“We believe that the hybrid design of Orsiro will minimize the potential for late adverse events due to its gently degrading bioabsorbable polymer,” commented Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. “This bioabsorbable polymer leaves only a thin-strut stent, optimally sealed from contact with tissue because of BIOTRONIK’s unique passive PROBIO coating.”
As a next step, BIOTRONIK is planning a comprehensive clinical strategy to support the Orsiro Hybrid DES. BIOFLOW-II, a pan-European, randomized, controlled trial with 440 patients comparing Orsiro with Xience Prime™ DES, is currently being initiated. Enrollment in BIOFLOW-III, a global, open-label registry that will include 1000+ patients, will begin shortly.
“BIOTRONIK already offers a strong coronary and peripheral passive device portfolio, and we will continue to introduce innovative technologies such as last year’s drug-eluting balloon (DEB), Pantera Lux,” continued Aimonetti. “The exciting addition of the Orsiro Hybrid DES 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.”
About BIOTRONIK SE & Co. KG
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.
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