May 18, 2011—Biotronik announced that Prof. Martial Hamon, MD, presented the final first-in-man (FIM) results from the BIOFLOW-I trial on the use of the Orsiro hybrid drug-eluting stent (DES) at the EuroPCR 2011 conference in Paris. Professor Hamon serves as the Clinical Coordinating Investigator for the trial.
According to the company, 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 and in-stent late lumen loss at 9 months, which was evaluated by quantitative coronary angiography. 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 (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 the absence of death, stent thrombosis, and myocardial infarction, the company noted.
“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.”
Biotronik stated that the Orsiro hybrid DES combines passive and active components. The company’s ProBio passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. Its Biolute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. The device is based on the Biotronik’s Pro-Kinetic Energy bare-metal stent platform with a thin-strut stent design.
The company advised that it is planning a comprehensive clinical strategy to support the Orsiro hybrid DES. BIOFLOW-II, a European, randomized, controlled trial with 440 patients comparing Orsiro with Xience Prime DES (Abbott Vascular, Santa Clara, CA), is currently being initiated. Enrollment in BIOFLOW-III, a global, open-label registry that will include 1,000-plus patients, will begin shortly.
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