Long-Term Outcomes Reported for Neovasc’s Reducer Device to Treat Refractory Angina

March 2, 2021—Neovasc, Inc. announced that findings from a multicenter study of long-term outcomes of patients undergoing coronary sinus reducer implantation with the company’s Reducer device were published by Maayan Konigstein, MD, et al in Clinical Cardiology.

According to the company, the study enrolled 99 patients between September 2010 and October 2017. Patients were followed for a mean of 3.9 years (minimum, 2.1; maximum, 8.5). The mean Canadian Cardiovascular Society (CCS) angina class was 3.1 ± 0.5 at baseline and improved to 1.66 ± 0.8 at 1 year (P < .001). CCS class remained low through 2 years and at last follow-up (1.72 ± 0.8 and 1.71 ± 0.8; P > .5 for both, in comparison to 1 year).

At baseline, 91% of patients reported severe disabling angina (CCS class 3-4). At 1 year, only 17.9% experienced disabling angina (P < .001), and this portion remained low over time (19% at last follow up). There were no procedure-related complications.

“Refractory angina has historically been very difficult to treat effectively,” commented Dr. Konigstein in the company’s announcement. “It’s reassuring to see the long-term sustained safety and clinical benefits of the Reducer therapy. The majority of patients treated with the Reducer experienced long-term relief of angina as well as improvement in their quality of life.” Dr. Konigstein is with Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, in Tel Aviv, Israel.

Neovasc stated that the Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes.

The Reducer has received CE Mark approval in the European Union for the treatment of refractory angina. In the United States, the Reducer is not approved for commercial use but was granted FDA Breakthrough Device designation in October 2018.