Elixir Medical Receives Regulatory Approval for DynamX Coronary Bioadaptor System
核心洞察
Japan's Ministry of Health, Labour and Welfare approved Elixir Medical (搜索)'s DynamX Coronary Bioadaptor System (搜索) for coronary artery disease (搜索), creating a new medical device category in Japan.
DynamX is the first coronary implant approved in Japan to restore arterial hemodynamic modulation after PCI, with improved survival and fewer re-interventions versus drug-eluting stents.
Approval rests on the BIOADAPTOR RCT and INFINITY-SWEDEHEART randomized trials, which compared DynamX with the Resolute Onyx drug-eluting stent.
Elixir Medical (搜索) said Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the DynamX Coronary Bioadaptor System (搜索) for the treatment of coronary artery disease (搜索). According to the company, DynamX is the first coronary implant approved in Japan to restore arterial function known as hemodynamic modulation after percutaneous coronary intervention (PCI), with demonstrated improved patient survival and reduced re-interventions compared with drug-eluting stents (DES). The approval establishes bioadaptor as a new medical device category in Japan.
The filing is supported by two randomized controlled trials, the global BIOADAPTOR RCT and the European INFINITY-SWEDEHEART study, both comparing DynamX with the standard-of-care Resolute Onyx drug-eluting stent. Four-year results from BIOADAPTOR RCT presented at EuroPCR 2026 showed a 66% reduction in target lesion failure versus DES (2.8% vs 7.8%; p=0.02) and a cardiovascular death rate of 0.5% versus 3.7% (p=0.02), along with fewer new heart attacks and repeat revascularization procedures. In INFINITY-SWEDEHEART, which enrolled 2,400 complex patients and patients with acute coronary syndrome, DynamX showed a consistent 48% improvement in clinical outcomes over DES after the bioadaptor's hemodynamic mechanism was activated six months post implant.
The DynamX Sirolimus Eluting Coronary Bioadaptor System is CE-marked and holds FDA Breakthrough Device Designation, and remains investigational in the United States. Elixir Medical (搜索) said it plans to work with the Japanese Association of Cardiovascular Intervention and Therapeutics and cardiology centers across Japan to introduce the device, pending reimbursement approval.
Source: Elixir Medical Announces Regulatory Approval of DynamX Coronary Bioadaptor System