Neovasc to explore HDE approval pathway, alternate trial designs for Reducer
Neovasc announced that the FDA has provided guidance to the company following its Sprint Discussion on June 26, together with the company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer, to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need. In its guidance, the FDA has recommended that the company consider potential alternate approaches such as: the Humanitarian Device Exemption pathway for class IV refractory angina patients and/or alternate clinical trial designs for a broader refractory angina patient population. Based on the FDA's feedback, the company has decided to explore a two-pronged approach. First, the company will work with the FDA to pursue the option for the Reducer to be classified as a Humanitarian Use Device seeking an HDE approval pathway in order to bring this treatment option to those patients in the U.S. with the worst angina symptoms as soon as possible. Second, the company, in close consultation with the FDA and key opinion leaders, will evaluate an alternate investigational device exemption clinical trial design for class III and IV patients.