Elixir Medical’s DynamX Coronary Bioadaptor System Approved in Japan

September 15, 2026—Elixir Medical announced that Japan’s Ministry of Health, Labor, and Welfare has approved the DynamX coronary bioadaptor system for the treatment of coronary artery disease (CAD).

According to the company, the DynamX coronary implant is approved in Japan to restore arterial hemodynamic modulation after percutaneous coronary intervention (PCI) procedures, with demonstrated improved patient survival and reduced reinterventions compared to drug-eluting stents. The approval establishes bioadaptor as a new medical device category in Japan, noted Elixir.

The company advised that pending reimbursement approval, it plans to work with the Japanese Association of Cardiovascular Intervention and Therapeutics and leading cardiology centers across Japan to introduce this treatment option to patients with CAD.

“The DynamX bioadaptor represents a major new treatment in PCI by providing restoration of the artery function,” commented Shigeru Saito, MD, in the company’s press release. Dr. Saito, who serves Principal Investigator of BIOADAPTOR randomized controlled trial (RCT), is Director of the Cardiac Center at Shonan Kamakura General Hospital in Kamakura, Japan.

Dr. Saito continued, “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.”

Elixir stated that approval of DynamX is supported by clinical evidence generated from two large RCTs, the BIOADAPTOR RCT and the INFINITY-SWEDEHEART RCT, which compared DynamX with the standard-of-care Resolute Onyx drug-eluting stent (Medtronic).

In the global BIOADAPTOR RCT trial, DynamX demonstrated restoration of pulsatility, compliance, and increased blood flow volume. In May 2026, the company announced that the 4-year results from BIOADAPTOR RCT presented at the EuroPCR 2026 conference.

In September 2024, Elixir Medical announced that the results of the INFINITY-SWEDEHEART RCT were presented at the European Society of Cardiology congress.

Elixir Medical advised that the DynamX has received European CE Mark approval. In the United States, it is an investigational device limited by Federal law to investigational use.