Shockwave Medical Demonstrates Consistent, Results In 'Real-World' Study; Investigators Presented 6-Month Data From The Full Population Of The REDUCER-I Study, Alongside Interim Long-Term Follow-Up Results To 3-Years

Shockwave Medical, Inc. (NASDAQ:SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today announced that investigators presented six-month data from the full population of the REDUCER-I study, alongside interim long-term follow-up results to three years. These findings confirm the positive, ‘real-world' outcomes of Shockwave Reducer, a novel technology for the treatment of refractory angina. Results were presented earlier today at the 73rd Annual Scientific Sessions of the American College of Cardiology in Atlanta, GA.

 

REDUCER-I is a post-market, multi-center, observational study designed to collect long-term outcomes on Shockwave Reducer in a large, ‘real-world' population of 400 patients. The lead enrollers of the study were Drs. Stefan Verheye1, ZNA Middelheim Hospital, Antwerp, Belgium, Tim van de Hoef, University Medical Center Utrecht, Utrecht, Netherlands, and Ranil de Silva, Royal Brompton and Harefield Hospitals, London, United Kingdom.

The primary effectiveness endpoint for the study was the percentage of patients experiencing improvement in their symptoms of angina defined as a reduction in Canadian Cardiovascular Society (CCS) grade at six months compared with baseline. The primary safety endpoints were the rate of device- and/or procedure-related periprocedural serious adverse events (SAEs) and major adverse cardiac events (MACE) up to 30 days post implant.

Six-month results demonstrated an improvement in ≥1 CCS class in 70% of patients, and ≥2 CCS classes in 24% of patients. The proportion of patients with CCS class III/IV declined from 72% at baseline to 18% at six months, with a mean change in CCS class of -0.9 ± 0.8 (p<0.0001). Reduction in symptoms of angina was consistent at longer-term follow-up, with CCS class III/IV symptoms experienced by only 15% of patients at two years and 11% at three years (p<0.0001). Use of Shockwave Reducer also demonstrated a very favorable safety profile, with SAE and MACE rates uniformly low at 1.1% and 1.6%, respectively.

"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.