Neovasc’s Reducer System Receives National Reimbursement in France to Treat Refractory Angina

November 30, 2021—Neovasc Inc. announced that the company’s Reducer system has been granted Prise en Charge Transitoire (PECT) reimbursement in France by the national health authority, Haute Autoritté de Santé (HAS). The Reducer has CE Mark approval in the European Union for the treatment of refractory angina.

The company noted that PECT is France’s newly established reimbursement approval process. It is designed to allow patients with significant illnesses and no other therapeutic options to benefit from novel therapies for select indications. The national approval is for a period of 1 year, and it can be renewed.

Professor Martine Gilard, MD, who is Past President of the French Society of Cardiology and Director of Interventional Cardiology at Brest University Hospital in Brest, France, commented in Neovasc’s press release, “This is positive news for patients suffering from refractory angina in France. The clinical data on Reducer therapy continue to demonstrate efficacy and an excellent safety profile. It is a strong message from HAS that the very first therapy approved under the innovative PECT process is the Reducer. This authorization is a major step for Reducer therapy and will help new centers in France to begin utilizing the device.”

The company noted that the Reducer is not approved for commercial use in the United States but received the FDA’s Breakthrough Device designation in October 2018.