New Cardiovascular Device Approved in Japan: Elixir Medical Announces Regulatory Approval of DynamX® Coronary Bioadaptor System
MILPITAS, Calif. and TOKYO , Sept. 14, 2026 (GLOBE NEWSWIRE) -- New Cardiovascular Device Approved in Japan: Elixir
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MILPITAS, Calif. and TOKYO , Sept. 14, 2026 (GLOBE NEWSWIRE) — New Cardiovascular Device Approved in Japan: Elixir Medical Announces Regulatory Approval of DynamX® Coronary Bioadaptor System
MILPITAS, Calif. and TOKYO — Elixir Medical today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease, making DynamX® the first and unique coronary implant approved in Japan to restore arterial function known as hemodynamic modulation after percutaneous coronary intervention (PCI) procedure, with demonstrated improved patient survival and reduced re-interventions compared to drug-eluting stents (DES).
The approval establishes bioadaptor as a new medical device category in Japan, highlighting MHLW and PMDA’s leadership in adopting the latest clinical innovations to advance cardiovascular treatment in Japan.
“The DynamX® bioadaptor represents a major new treatment in PCI by providing restoration of the artery function,” – remarked Shigeru Saito, M.D., principal investigator of BIOADAPTOR RCT trial and Director of the Cardiac Center at Shonan Kamakura General Hospital in Kamakura, Japan. “With demonstrated evidence of restored hemodynamic modulation and the significant improvement in clinical outcomes in randomized trials, I believe this will become the new standard of care for coronary artery disease treatment.”
“Coronary arteries perform two main functions – conduct blood flow and maintain healthy wall function that adapts to changing cardiac workload through pulsatility, elastic expansion and contraction, compliance, known together as hemodynamic modulation. This important function is disrupted when atherosclerotic plaques thicken the artery wall and progress into severe blockages,” noted Professor Stefan Verheye, M.D., Ph.D., leading bioadaptor researcher and interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium. “For decades we focused on opening artery blockages with stents and balloons to establish flow but did not address the hemodynamic modulation function of the artery resulting in adverse events increasing over time. DynamX bioadaptor is the first and only CAD treatment to achieve restoration of blood flow by both, opening the blockage and regaining hemodynamic modulation function of the artery, leading to demonstrated significant improvement in outcomes compared to current treatments.”
DynamX® approval is supported by strong clinical evidence generated from two large RCT trials, the BIOADAPTOR RCT and INFINITY-SWEDEHEART randomized controlled trials, which compare DynamX® bioadaptor system with the standard-of-care Resolute Onyx™ drug-eluting stent.
In the global BIOADAPTOR RCT trial, DynamX® demonstrated restoration of pulsatility, compliance and increased blood flow volume, representing for the first time restoration of both, blood flow and arterial functions. Recent long-term four-year results from BIOADAPTOR RCT presented at EuroPCR 2026 conference showed a significant 66% reduction versus DES in target lesion failure rate (2.8% vs 7.8%; p =0.02) DynamX® vs. DES, along with a significant 88% improvement in cardiovascular survival (cardiovascular death rate of 0.5% versus 3.7%, p=0.02), reduction in new heart attacks, and fewer repeat revascularization procedures. In the large European INFINITY-SWEDEHEART study of 2,400 complex patients and patients with acute coronary syndrome, DynamX® demonstrated similar and consistent 48% improvement in clinical outcomes over drug-eluting stent following activation of bioadaptor’s mechanism of restoring hemodynamic function six months post implant.
The approval of DynamX® bioadaptor in Japan as a new medical device category for the treatment of coronary artery disease in addition to FDA’s Breakthrough Device Designation status, reflect growing recognition of bioadaptor implant’s unique mechanism of action, proven treatment effects, and demonstrated clinical improvement in PCI outcomes compared to existing standard of care.
“MHLW approval marks an important milestone for patients and physicians in Japan and for the evolution of coronary artery disease treatment,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “We developed DynamX® to move beyond the limitations of metallic drug-eluting stents and the “leave nothing behind” approaches by freeing the vessel while providing ongoing structural dynamic support to the diseased segment of the vessel, enabling the artery to regain its normal function after PCI. This approval is a big win for patients.”
Pending reimbursement approval, Elixir Medical plans to work closely with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and leading cardiology centers across Japan to introduce this new treatment option to patients with coronary artery disease.
About DynamX® Sirolimus Eluting Coronary Bioadaptor System
The DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through four-year clinical follow-up.
The DynamX® Sirolimus Eluting Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device, limited by Federal (or United States) law to investigational use.
About Elixir Medical
Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn.
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