Elixir Medical today announced new landmark clinical results for its DynamX bioadaptor coronary implant system.
Milpitas, California-based Elixir Medical’s sirolimus-eluting DynamX bioadaptor features a novel design and mechanism of action designed to return the diseased vessel to a more normal condition. It aims to restore blood flow to treat symptoms of coronary artery disease (CAD).
DynamX directly addresses existing issues with currently available stent devices. It unlocks, adapts and allows the artery to heal and return to natural motion after patients no longer need fixated support. The company said this represents a key limitation of drug-eluting stents.
Elixir won FDA breakthrough device designation for DynamX last year. The system has CE mark but remains investigational in the U.S. The company shared positive findings for the system in May.
Today, the company reports new findings demonstrating a 48% risk reduction in device-related cardiac events compared to a current-generation drug-eluting stent. It shared findings at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
Results included a 48% reduction in the target lesion failure (TLF) endpoint. This encompasses reductions in cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. Data spanned evaluation from six months through two years in a prespecified landmark superiority analysis.
Additional findings include a significant reduction in target vessel failure (TVF) and substantial clinical benefit for high-risk patients with acute coronary syndrome (ACS).
“The INFINITY-SWEDEHEART long-term landmark results confirm our trial design hypothesis, demonstrating separation of the event curves for TLF at six months and maintaining consistency up to two years with a reduction of TLF by 48%. Our data validates the unique property of the bioadaptor of restoring coronary physiology after unlocking after half a year, which translates into improved clinical outcomes long-term,” said Dr. David Erlinge, head of the Cardiology Department at Lund University, Lund, Sweden, and principal investigator.
