FDA Does Not Approve Neovasc’s Reducer

January 15, 2021–Neovasc Inc. announced that it has received a not-approvable letter from the FDA regarding the company’s premarket approval submission for the Neovasc Reducer for the treatment of refractory angina. The device has been commercially available in Europe since 2015.

The FDA reviewed Reducer for the treatment of patients with refractory angina pectoris despite guideline-directed medical therapy, and who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

“While we are disappointed in FDAs decision, the letter was not unexpected, given the outcome of the Panel meeting,” commented Fred Colen, CEO of Neovasc, in the company’s press release. “Millions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.”

The Circulatory Devices Panel of the FDA Center for Devices and Radiological Health’s Medical Devices Advisory Committee met virtually via Zoom on October 27, 2020 to consider Neovasc’s PMA submission for the Reducer. The meeting information and event materials, including the FDA’s transcript of the meeting and the panel questions and discussion of the meeting, are available online.