Two-year data from a trial of the Reducer anti-angina device made by Neovasc (NSDQ:NVCN), published this week in the International Journal of Cardiology, bore out earlier safety and efficacy results but showed no effect on the progression of coronary artery disease.
The study examined angina symptoms, quality of life and adverse events at two years, in a 50-patient cohort implanted at Milan’s San Raffaele Hospital between March 2015 and August 2016. Reducer, designed to narrow the coronary sinus, showed no device-related adverse events at the two-year mark.
Measured using the Canadian Cardiovascular Society’s angina grading scheme, more than three-fourths of the patients improved by at least one grade and nearly 36% improved by at least two CSS grades, “translating into a significant mean CCS score reduction at 2-year follow-up,” the authors found. Reducer also delivered significant improvement in four of five Seattle Angina Questionnaire items.
Ten patients or 22% received percutaneous coronary intervention, three for acute coronary syndromes, according to the study, “underlining that Reducer does not affect coronary artery disease progression.” Five patients died, two for cardiovascular causes (stroke and cardiac arrest).
“This study shows us that the Reducer has a sustained therapeutic effect at two years across a large patient population. In addition, we believe this study provides valuable long-term safety data that further supports cardiologists use of the Reducer as a therapeutic option for patients suffering from refractory angina,” Neovasc medical director Dr. Shmuel Banai said in prepared remarks. “This data supports our belief that the Reducer offers refractory angina patients a safe and effective treatment option, filling a void in a market where there are currently limited therapeutic options.”
The news pushed NCVN shares up some 42% to 66.95¢ apiece today in late-morning trading.
