At a recently concluded EuroPCR 2011 Congress in Paris, France, researchers presented results from the first in man trial of BIOTRONIK’s Orsiro Hybrid Drug-Eluting Stent. This is the company’s up and coming solution that combines two different types of coating: one that does not elicit body response to the implant, and the other one that features a bioabsorbable matrix with a slow-release limus drug.
BIOTRONIK’s product description:
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.
More about the BIOFLOW-I trial:
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).
Press release: Industry’s First Hybrid Drug-Eluting Stent from BIOTRONIK demonstrates Safety and Efficacy in First-in-Man Clinical Experience …
Product page: Orsiro …
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