Neovasc’s Reducer System Receives Positive Guidance From United Kingdom’s NICE

November 24, 2021—Neovasc Inc. announced that the United Kingdom’s Interventional Procedures Program at the National Institute for Health and Care Excellence (NICE) has issued guidance supporting the implantation of the Neovasc Reducer in appropriate patients with refractory angina when other treatment options have failed or are not possible.

According to the company, NICE’s current guideline on stable angina describes recommendations on managing stable angina that has not responded to treatment. For these stable angina patients who are refractory to treatment, NICE has limited its recommendations to addressing the psychological factors of patients’ pain. The company noted that before the new guidance supporting coronary sinus reduction, NICE has not supported any therapeutic interventions.

Neovasc quoted the new guidance document, as follows: “Coronary sinus narrowing device implantation is indicated for people in whom other treatment options (medical or surgical) have failed or are not possible (refractory angina). The aim is to reduce symptoms and to improve quality of life.”

Further, the company advised that the coronary sinus narrowing device was recommended by NICE with “Special Arrangements.” Such a recommendation, according to NICE, "...is often made when the procedure is considered to be emerging practice in the National Health Service.”

The recommendation places emphasis on the need for informed consent and suggests that clinicians using these procedures should collect data and enter them into a national database. The guidance further recommends that patient selection should be done by a multidisciplinary team and the procedure should only be done in centers by interventional cardiologists with specific training in the technique, stated the company.

Professor Jonathan Hill, MD, commented in Neovasc’s press release, “The NICE committee that evaluated the coronary sinus narrowing device extensively reviewed the available clinical data regarding the Reducer device. Today’s guidance document is good news for patients in the United Kingdom suffering from refractory angina that haven’t had treatment options supported by NICE guidance.” Prof. Hill is Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust in London, United Kingdom.

The Reducer device received CE Mark approval in the European Union for the treatment of refractory angina. The Reducer is not approved for commercial use in the United States, but it has been granted Breakthrough Device designation by the FDA, noted the company.