Shockwave Medical to acquire NeoVasc and with it the NeoVasc Reducer System for treatment of refractory angina

The Neovasc Reducer System is a first-of-its-kind technology to address refractory angina. Refractory angina is a chronic condition in which a patient suffers chest pain that cannot be controlled by conventional therapies. It is estimated that each year, in the United States and the European Union alone, up to 300,000 new patients with obstructive coronary disease who are ineligible for conventional revascularization experience refractory angina, despite guideline-directed medical therapy. In addition, it is estimated that up to another 500,000 new patients present with angina and non-obstructive coronary artery disease in the U.S. and the E.U. each year. The Reducer has been granted Breakthrough Device designation by the FDA , is CE-marked and is currently enrolling patients in the COSIRA-II study, a randomized clinical trial being conducted under an Investigation Device Exemption intended to support FDA approval for patients with coronary obstructive refractory angina.