Neovasc’s Reducer System to Treat Refractory Angina Evaluated in Real-World RESOURCE Registry

June 18, 2021—Neovasc Inc. announced the publication of long-term outcomes of patients experiencing refractory angina treated with the Neovasc Reducer system, which 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.

Francesco Ponticelli, MD, et al published safety and efficacy data from the RESOURCE study in the International Journal of Cardiology.

According to the company, the RESOURCE study is an observational, retrospective registry composed of 658 patients with refractory angina from 20 centers in Europe, the United Kingdom, and Israel. The prespecified endpoints of the trial were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score and the rates of procedural success and complications.

The company reported that at a median follow-up of 502 days after Reducer implantation, the investigators found 39.7% of patients improved by ≥ 2 CCS classes (primary endpoint), and 76% by ≥ 1 class. The procedure was safe and procedural success was achieved in 96.7% of attempts. Additionally, there were no cases of intra- or periprocedural death, myocardial infarction, or cardiac tamponade in the study population. No patient required bailout conversion to open surgery. The investigators described the study as the largest international real-world registry of patients with refractory angina who were treated with the coronary sinus Reducer.

“The data presented in the RESOURCE study confirm the excellent safety profile of the Reducer device and support good clinical efficacy,” commented Dr. Ponticelli in Neovasc’s press release. “It’s encouraging to see the results in this real-world registry are consistent with the randomized data on the Reducer. We can now more confidently tell our patients suffering from refractory angina that there is a safe therapy that may be able to help them feel better.”

The Reducer has received CE Mark approval for the treatment of refractory angina in the European Union, where it has been commercially available since 2015. In the United States, the Reducer is not approved for commercial use but was granted Breakthrough Device designation by the FDA in October 2018.