Neovasc’s Reducer Device Studied in COSIMA Trial for Refractory Microvascular Angina

May 10, 2021—Neovasc Inc. announced that the first patient has been enrolled in the COSIMA randomized controlled trial of the company’s coronary sinus Reducer device for the treatment of refractory microvascular angina.

According to Neovasc, the COSIMA study will enroll up to 144 patients across multiple centers in Germany. The trial will include patients with objective evidence of ischemia documented by noninvasive testing (eg, cardiac stress test) who are not good candidates for traditional stenting or bypass surgery and who have evidence of an elevated index of microvascular resistance.

The primary endpoint of the study is change in Canadian Cardiovascular Society (CCS) angina class by two or more classes.

Patients enrolled in the trial will be randomized to one of two groups. Patients in the treatment arm will receive the Reducer and continue with their optimized medications. Patients in the control arm will not receive the Reducer but will continue with their optimized medications. Patients will be followed for an initial period of 6 months to determine the outcomes of the two treatment strategies.

The study, supported by Neovasc, is being led by Professor Tommaso Gori, MD, of the University Medical Center in Mainz, Germany. Helen Ullrich, MD, from University Medical Center, Mainz, enrolled the first patient in the trial. The patient is an 82-year-old woman with severe CCS class IV angina on a daily basis despite optimal medical treatment.

“Microvascular angina is a common condition that affects millions of patients worldwide, and it disproportionately affects women,” commented Dr. Ullrich in Neovasc’s press release. “Preliminary case reports have suggested Reducer may be a beneficial treatment for microvascular angina. The COSIMA trial is important because it will provide robust data on the performance of the Reducer in this important, underserved population.”

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