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# Neovasc PMA for Reducer Accepted for Review
- URL: https://www.fdaweb.com/neovasc-pma-for-reducer-accepted-for-review/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145851

FDA has accepted for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina. The device is intended to relieve angina symptoms by altering blood flow within the heart’s myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle, the company says. Placement of the device is performed using a transvenous procedure that is similar to implanting a coronary stent and is completed in about 20 minutes, it says.

The PMA includes clinical data from COSIRA, a 104-patient randomized, double-blind, sham-controlled trial. It also includes data from REDUCER-I, a European post-market study in over 200 patients with up to five years of follow-up.