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Six-month results from REDUCER-I trial add to positive evidence for coronary sinus-reducing agents in the treatment of refractory angina
SANTA CLARA, Calif., April 8, 2024 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of innovative technologies for the treatment of cardiovascular disease, today announced that research announced that they had published six research results. Monthly data and interim long-term follow-up results up to 3 years from the entire population of the REDUCER-I study. These findings support the positive “real world” results of Shockwave Reducer, a new technology for the treatment of refractory angina. The results were announced earlier today at the 73rd General Assembly.rd Annual Scientific Sessions of the American College of Cardiology, Atlanta, Georgia.
REDUCER-I is a post-marketing, multicenter, observational study aimed at collecting long-term outcomes of Shockwave Reducer in a large “real-world” population of 400 patients. The primary enrollee of this study was Dr.Stefan Verhey1ZNA Middleheim Hospital (Antwerp, Belgium), Tim van de Hef, Utrecht University Medical Center (Utrecht, The Netherlands), Ranil de Silva, Royal Brompton Hospital and Harefield Hospital (London, UK).
The primary efficacy endpoint of this study was the proportion of patients who experienced improvement in angina symptoms, defined as a decrease in Canadian Cardiovascular Society (CCS) grade at 6 months compared to baseline . The primary safety endpoint was the incidence of device- and/or procedure-related perioperative serious adverse events (SAEs) and major adverse cardiac events (MACE) up to 30 days post-implant.
Six-month results showed improvement in 1 or more CCS classes in 70% of patients and improvement in 2 or more CCS classes in 24% of patients. The proportion of patients in CCS class III/IV decreased from 72% at baseline to 18% after 6 months, with a mean change in CCS class of -0.9 ± 0.8 (p<0.0001). Reduction in angina symptoms was consistent over long-term follow-up, with only 15% of patients experiencing CCS class III/IV symptoms at 2 years and 11% at 3 years (p<0.0001 ). Use of Shockwave Reducer also showed a very good safety profile with uniformly low SAE and MACE rates of 1.1% and 1.6%, respectively.
“The results of the REDUCER-I study continue to demonstrate the safety and efficacy of Shockwave coronary sinus reducer as a new treatment for refractory angina,” said Dr. Verhey. “We observed consistent reductions in refractory angina symptoms and improvements in quality of life. This result is consistent with the results of the previously published COSIRA study.” New England Medical Journal, In a challenging patient cohort characterized by high rates of cardiovascular risk factors and comorbidities that historically had no other treatment options. ”
COSIRA-II, a U.S. IDE double-blind randomized sham-controlled clinical trial, is now further testing the safety and efficacy of Shockwave Reducer in the treatment of patients with refractory angina who do not have conventional revascularization options. Enrolling patients for evaluation. The COSIRA-II results are intended to support the regulatory filing for approval of Shockwave Reducer by the US FDA. The Shockwave Reducer is a research device and is restricted to research use by U.S. law.
Additional reducer data presented at ACC
In another Latest Clinical Trials session at ACC, Michael Foley, MD, of the National Heart and Lung Institute, Imperial College, London, UK, presented data from the ORBITA-COSMIC trial (principal investigator Rasha Al Rami, PhD; (M.D.) is a randomized, placebo-controlled, double-blind, multicenter trial investigating the efficacy of Shockwave coronary sinus shrinking agent. This study confirmed that angina symptoms decreased over time in patients who received the reducer. Although the primary imaging endpoint of myocardial blood flow assessed by magnetic resonance imaging was not achieved in this trial, there was evidence of redistribution of blood flow to subendocardial ischemic areas and Shockwave This confirmed the presumed mechanism of action of Reducer. ORBITA-COSMIC provides further evidence for the use of Reducer as an additional treatment option for patients with refractory angina, proven myocardial ischemia, and no traditional revascularization options.
About Shockwave Medical Co., Ltd.
Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first intravascular lithotripsy (IVL) technology transforms the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to destroy difficult calcified plaques, resulting in , significantly improved patient outcomes. Shockwave Medical also recently acquired Reducer. Reducer is under clinical research in the United States and Canada, and has received his CE mark in the European Union and United Kingdom. Reducer is designed to provide relief to millions of patients worldwide who suffer from refractory angina by redistributing blood flow within the heart. For more information, please visit www.shockwavemedical.com.
About reducer
Shockwave Reducer is used to treat intractable angina, a painful and debilitating disease that occurs when the coronary arteries do not provide enough blood to the heart muscle, despite treatment with standard revascularization and cardiac medications. It is CE marked in the European Union for therapeutic use. This disease affects millions of patients worldwide, who typically live severely limited lives as a result of disabling symptoms, and its incidence is increasing. Reducers have been shown to reduce angina symptoms in patients who do not have traditional revascularization options. Reducer placement is performed using a minimally invasive transvenous procedure. Although Reducer has not been approved for commercial use in the United States, the FDA granted Breakthrough Device designation to Reducer in October 2018 and it is being studied in the COSIRA-II clinical trial.
Forward-looking statements
This press release contains statements regarding our expectations, projections, beliefs and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, these statements may be identified as forward-looking. “may”, “might”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, ” Look for words like “predict,” “may,” and “continue.” ” and its negative expressions. Forward-looking statements in this press release include, but are not limited to, statements regarding the likely future results of pending clinical trials, the timing and effectiveness of regulatory approvals for our products, and our ability to obtain them. It will not be. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are predictions only that are based on our current expectations, estimates and assumptions, are valid only as of the date on which they are made, and are subject to risks and uncertainties not currently known to us. There is a possibility that you will receive it.
For a description of important factors that could cause our actual results of operations and financial condition to differ materially from those expressed in the forward-looking statements, please refer to our Securities and Exchange Commission (SEC) filings. It is explained inside. Our most recent annual report is on Form 10-K and our subsequent quarterly reports are on Form 10-Q and other reports filed with the SEC. Except to the extent required by law, we do not intend to update these forward-looking statements after the date hereof to conform them to actual results or revised expectations. We do not promise
Media contact:
scott shadow
+1.317.432.9210
sshadiow@shockwavemedical.com
Investor contact information:
Debbie Custer
dkaster@shockwavemedical.com
1Dr. Verhey is a paid consultant for Shockwave Medical. He received no compensation in connection with this press release.
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