Shockwave Reducer Demonstrates Consistent, Positive Results in ‘Real-World’ Study
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The six-month results from the REDUCER-I trial presented by Shockwave Medical, Inc. offer significant insights into the treatment of refractory angina, a chronic condition that affects a substantial patient population and has historically lacked effective treatment options. The data indicating that 70% of patients experienced an improvement of ≥1 Canadian Cardiovascular Society (CCS) class and the reduction in symptoms persisted through longer-term follow-up, are particularly noteworthy.
This persistent symptom relief could potentially translate into lower healthcare costs and improved patient quality of life, which are critical considerations for healthcare providers and payers. Moreover, the low rates of serious adverse events (SAEs) and major adverse cardiac events (MACE) suggest a favorable safety profile, which is essential for patient acceptance and widespread clinical adoption.
As the device is still investigational in the U.S., the results from the ongoing COSIRA-II trial will be pivotal in determining the regulatory pathway and future market potential. The ability to provide symptomatic relief without conventional revascularization could position Shockwave Reducer as a game-changer in the cardiovascular treatment landscape, subject to FDA approval.
The impact of the Shockwave Reducer on patients with refractory angina, as evidenced by the REDUCER-I trial, suggests a significant advancement in the management of a condition that limits patients' daily activities and diminishes their quality of life. The observed improvements in CCS grades indicate not just statistical significance, but also clinical relevance, as a reduction in angina class correlates with better exercise tolerance and functional capacity.
From a cardiological perspective, the potential redistribution of blood flow to ischemic regions, as suggested by the ORBITA-COSMIC trial, could represent a novel therapeutic mechanism that addresses the underlying pathophysiology of refractory angina. This could be an alternative for patients ineligible for conventional procedures like angioplasty or bypass surgery.
However, the missed primary imaging endpoint in the ORBITA-COSMIC trial warrants a cautious interpretation of the results, emphasizing the need for further studies to fully understand the clinical implications of this therapy.
From an economic standpoint, the introduction of a novel therapy such as the Shockwave Reducer has the potential to disrupt the current treatment paradigm for refractory angina. The reduction in angina symptoms and the potential decrease in the need for more invasive procedures could lead to a shift in healthcare resource allocation.
With the prevalence of cardiovascular diseases and the associated economic burden, therapies that offer symptom management with a strong safety profile could be highly valued by both healthcare systems and insurers. However, cost-effectiveness analyses would be required to assess the long-term economic implications of adopting this technology on a wider scale.
Additionally, the eventual market entry of the Shockwave Reducer, pending FDA approval, could stimulate competitive dynamics within the cardiovascular device industry, potentially affecting stock market valuations of companies in this sector.
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 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
“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.
About Reducer
Shockwave Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. Reducer has been shown to provide relief from symptoms of angina in patients lacking conventional revascularization options. Placement of Reducer is performed using a minimally invasive transvenous procedure. While Reducer is not 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.
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Media Contact:
Scott Shadiow
+1.317.432.9210
sshadiow@shockwavemedical.com
Investor Contact:
Debbie Kaster
dkaster@shockwavemedical.com
1Dr. Verheye is a paid consultant of Shockwave Medical. He has not been compensated in connection with this press release.
FAQ
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