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5 June 2013 – Biosensors International has announced enrolment of the first patient in a Canadian study of BioMatrix Flex™, one of its Biolimus A9™-eluting stents with biodegradable polymer coating, following approval of the study protocol by Health Canada. The stent was inserted by Dr Luc Bilodeau, Director of the Cardiac Catheterization Laboratory, Royal Victoria Hospital, McGill University Health Center, Montreal.
e-BioMatrix Canada is a pre-market prospective registry being conducted at six Canadian interventional cardiology centers, enrolling over 500 “on label” patients. The data obtained from these patients will be compared with that from a historical control group of equivalent patients from the Cypher® Select™ arm of the LEADERS study.
The primary endpoint of the study is device-oriented MACE (Major Adverse Cardiac Events) and bleeding events within 12 months. MACE is defined as a composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave) or clinically-indicated target vessel revascularization. All patients will be followed up at 30 days, 6 months, 12 months and 2 years.
“This on-label registry, based on Health Canada requirements, will determine the efficacy of a biodegradable abluminal polymer coated medicated stent to prevent restenosis after coronary angioplasty”, said Dr Bilodeau. “Six Canadian cardiology centers will follow more than 500 treated patients for a period of two years. This new medicated stent combines the performance of Biolimus A9 to prevent recurrence of blockage after angioplasty, with the safety of a biodegradable coating in order to avoid clot formation.”
“This study is very important to us, as it represents an important step towards the registration of BioMatrix Flex in Canada”, added Jeffrey B. Jump, President of Biosensors’ Cardiovascular Division. “We are confident that the results will reinforce those of the LEADERS study, which demonstrated improved long-term clinical outcomes for BioMatrix Flex compared with Cypher Select.”
LEADERS was the first head-to-head randomized clinical trial (RCT) between two limus-eluting stents, BioMatrix Flex and Cypher Select. It was also the first RCT between two stents to involve an “all comers” patient population. Initial results, presented at the European Society of Cardiology (“ESC”) congress in 2008 and simultaneously published in The Lancet, demonstrated BioMatrix Flex to be non-inferior to Cypher Select with respect to the primary endpoint, incidence of MACE at nine months. Final five-year results, presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium in 2012, demonstrated the long-term benefits of BioMatrix Flex. Compared with Cypher Select, BioMatrix Flex significantly reduced the risk of clinical events, which was associated with a reduced risk of very late stent thrombosis (VLST).
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