Vancouver-based Neovasc ($NVC) has received CE Mark designation for its Reducerproduct for the treatment of refractory angina. The Reducer can be implanted quickly in a minimally invasive procedure and is designed to treat the roughly 1 million European patients who suffer from this condition.
Results from a published prospective three-year clinical study showed the Reducer is safe and effective at providing relief of angina symptoms. Neovasc is now enrolling patients in the multicenter, randomized, double-blind COSIRA trial, which is designed to provide additional efficacy data and support physician education and marketing efforts. It will also support additional regulatory applications to make the Reducer available in more markets.
"Achieving the European CE mark will allow this technology to be used in 'real world' patients and sets the stage for much needed clinical trials in the U.S.," said Christopher White, professor of medicine and system chair for cardiovascular diseases, the Ochsner Clinical School, University of Queensland, and medical director, John Ochsner Heart & Vascular Institute, Ochsner Medical Center.
- see the Neovasc release
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