Shockwave Medical (Nasdaq:SWAV) announced positive six-month and long-term real-world outcomes for its Reducer technology.
Investigators presented data at the American College of Cardiology (ACC) Scientific Sessions in Atlanta. Results included six-month data from the full REDUCER-I population and interim long-term follow-up results out to three years.
According to Shockwave, results confirm the positive real-world outcomes for the Reducer technology that treats refractory angina. Shockwave acquired the technology when it bought Neovasc for $147 million a year ago. The study marks the latest positive development for the company, which is set to be acquired for $13.1 billion by Johnson & Johnson.
The Reducer alters blood flow within the myocardium of the heart. It also increases the perfusion of oxygenated blood to ischemic areas of heart muscle. Placement occurs through a minimally invasive, transvenous procedure. The device remains investigational in the U.S. Shockwave has the COSIRA-II trial underway to evaluate the Reducer and support a submission for FDA approval.
REDUCER-1, a post-market observational study, aims to collect long-term outcomes on the Reducer in a real-world pool of 400 patients. It has a primary effectiveness endpoint of 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. Investigators defined primary safety endpoints as 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.
About the Reducer results from Shockwave Medical
Six-month results showed 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 dropped from 72% at baseline to 18% at six months.
Shockwave reported a consistent reduction in symptoms of angina at a longer-term follow up. Just 15% of patients experienced CCS class III/IV symptoms at two years, dropping to 11% at three years.
Use of the Reducer also demonstrated a favorable safety profile, Shockwave said. SAE and MACE rates came in uniformly low at 1.1% and 1.6%, respectively.
Dr. Stefan Verheye of the ZNA Middelheim Hospital in Antwerp, Belgium, served as a leading enroller in the study.
“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,” Verheye said. “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.”
Investigators also reported more positive data for the Reducer, coming from the ORBITA-COSMIC trial. The study confirmed symptomatic relief from angina over time in patients that had received Reducer.
This trial missed the primary imaging endpoint of myocardial blood flow assessed by magnetic resonance imaging. However, Shockwave said investigators saw evidence of the redistribution of blood flow to the subendocardial ischemic regions, supporting the putative mechanism of action of Shockwave Reducer.
