Shockwave Reducer Demonstrates Consistent, Positive Results in ‘Real-World’ Study - Seite 2

“Results from the REDUCER-I study continue to demonstrate the safety and effectiveness of Shockwave Coronary Sinus Reducer as a novel therapy for refractory angina,” said Dr. Verheye. “We observed consistent reduction in symptoms of refractory angina and improvements in quality of life, results which align with those from the COSIRA study, previously published in The New England Journal of Medicine, in a challenging patient cohort characterized by high rates of cardiovascular risk factors and coexisting comorbidities for whom there have historically been no other treatment options.”

COSIRA-II, a US IDE double-blind randomized sham-controlled clinical trial, is currently enrolling patients to evaluate further the safety and effectiveness of Shockwave Reducer for the treatment of patients with refractory angina and no conventional revascularization options. Results from COSIRA-II are intended to support the regulatory filing for US FDA approval of Shockwave Reducer. Shockwave Reducer is an investigational device, limited by U.S. law to investigational use.

Additional Reducer Data Presented At ACC
In a separate late-breaking clinical trial session at ACC, Michael Foley, MD, National Heart and Lung Institute, Imperial College, London, UK, presented data from the ORBITA-COSMIC trial (Principal Investigator Dr. Rasha Al-Lamee, MD PhD), a randomized, placebo-controlled, double-blind, multicenter trial investigating the efficacy of Shockwave Coronary Sinus Reducer. The study confirmed symptomatic relief from angina over time in patients that had received Reducer. Although the trial missed the primary imaging endpoint of myocardial blood flow assessed by magnetic resonance imaging, there was evidence of redistribution of blood flow to the subendocardial ischemic regions, supporting the putative mechanism of action of Shockwave Reducer. ORBITA-COSMIC provides additional evidence for the use of Reducer as an additional therapeutic option for patients with refractory angina, documented myocardial ischemia and no option for conventional revascularization.

About Shockwave Medical, Inc. 
Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave Medical has also recently acquired Reducer, which is under clinical investigation in the United States and Canada and is CE Marked in the European Union and the United Kingdom. By redistributing blood flow within the heart, Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at www.shockwavemedical.com.