Neovasc said treatment with its Reducer, a CE-Marked medical device designed for the treatment of refractory angina, was very safe and significantly reduced the severity of angina.
The company announced publication of the manuscript, “Safety and efficacy of the Reducer: A multicenter clinical registry – REDUCE study” in the International Journal of Cardiology.
In this published study, the safety and effectiveness of the Neovasc Reducer, a CE-Marked medical device designed for the treatment of refractory angina, was evaluated using a real-world cohort of 141 patients in three high-volume medical centers in Milan, Tel Aviv and Antwerp.
The researchers aimed to evaluate the efficacy of the Reducer in improving quality of life and reducing symptoms of angina pectoris in 141 consecutive patients suffering from coronary artery disease and chronic refractory angina. The safety endpoint of the study was to evaluate the rate of successful Reducer delivery and deployment in the absence of any device-related events.
The investigator demonstrated that treatment with the Reducer was very safe and significantly reduced the severity of angina as measured by the Canadian Cardiovascular Society classification (“CCS”) (from a mean at baseline of 3.05±0.53 to 1.63±0.98 at follow-up (p<0.001).
Overall, results show that 81% of the patients experienced improvement in their angina severity by at least one CCS class, and 45% of the patients became free of any limiting angina as they improved by 2 or more grades in their CCS class.
All parameters of quality of life as measured by the Seattle Angina Questionnaire improved significantly (p <0.001). These benefits translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37± 0.97 vs 2.17±0.95; p= 0.003).
Neovasc president and chief executive officer Fred Colen said: “The publication is another ‘real-world,’ non-randomized study which demonstrates clinical results in an additional 141 enrolled patients, that are remarkably consistent with the results of the COSIRA randomized sham-controlled clinical trial.
“This recent manuscript published in the International Journal of Cardiology is a testament to the benefits of the Reducer as a safe device, which can provide substantial qualify of life improvements in patients with refractory angina, who do not have other suitable treatment alternatives.”
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.
Its products include the Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe.
Source: Company Press Release