Neovasc Reducer Evaluated for Coronary Sinus Narrowing in Meta-Analysis

January 20, 2022—Neovasc, Inc. announced the publication of a meta-analysis assessing the effects of coronary sinus narrowing after treatment for refractory angina with the company’s Reducer device.

The study by Aviram Hochstadt, MD, et al is available online ahead of print in the Canadian Journal of Cardiology. The senior investigator is Maayan Konigstein, MD. Drs. Hochstadt and Konigstein are with Sourasky Medical Center and the Sackler School of Medicine, Tel Aviv University, in Tel Aviv, Israel.

According to the company, the meta-analysis was composed of 846 patients across nine prospective studies. The primary outcome was the proportion of patients improving ≥ 1 class in the Canadian Cardiovascular Society (CSS) angina score.

Neovasc reported that investigators found that improvement of ≥ 1 CSS class occurred in 76% (95% CI, 73%-80%) of patients. Improvement of ≥ 2 CSS classes was observed in 40% of patients (95% CI, 35%-46%). Procedure success was 98%. There were no major periprocedural complications and 3% minor periprocedural complications. Patients’ walking distances, as measured by the 6-minute walk test, also significantly improved.

“This meta-analysis of clinical studies describing the outcomes of patients with refractory angina implanted with the Reducer for coronary sinus narrowing demonstrates its safety and efficacy,” concluded the investigators in Neovasc’s press release. “The vast majority of patients experienced improvement in angina severity, quality of life, and functional performance.”

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