Elixir Medical has 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.
The approval establishes bioadaptor as a new medical device category in Japan, Elixir says in a press release.
“The DynamX bioadaptor represents a major new treatment in PCI [percutaneous coronary intervention] by providing restoration of the artery function,” Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan), principal investigator of the BIOADAPTOR RCT trial. “With demonstrated evidence of restored haemodynamic modulation and the significant improvement in clinical outcomes in randomised 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 haemodynamic modulation. This important function is disrupted when atherosclerotic plaques thicken the artery wall and progress into severe blockages,” noted Stefan Verheye (ZNA Cardiovascular Center, Antwerp, Belgium). “For decades we focused on opening artery blockages with stents and balloons to establish flow but did not address the haemodynamic modulation function of the artery resulting in adverse events increasing over time. DynamX bioadaptor is the first and only coronary artery disease (CAD) treatment to achieve restoration of blood flow by both, opening the blockage and regaining haemodynamic 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 randomised 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 (19–22 May, Paris, France) showed a significant 66% reduction versus drug-eluting stents (DES) in target lesion failure rate (2.8% vs 7.8%; p =0.02) DynamX versus DES, along with a significant 88% improvement in cardiovascular survival (cardiovascular death rate of 0.5% vs. 3.7%, p=0.02), reduction in new heart attacks, and fewer repeat revascularisation 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 haemodynamic 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 US Food and Drug Administration (FDA) breakthrough device designation status, reflect growing recognition of the bioadaptor implant’s unique mechanism of action, proven treatment effects, and demonstrated clinical improvement in PCI outcomes compared to existing standard of care, the company states.
“MHLW approval marks an important milestone for patients and physicians in Japan and for the evolution of coronary artery disease treatment,” said Motasim Sirhan, CEO 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 centres across Japan to introduce this new treatment option to patients with CAD.
