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

Six-Month Results from REDUCER-I Trial Add to Positive Evidence of the Coronary Sinus Reducer to Treat Refractory Angina

SANTA CLARA, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- 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 73^rd 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.