Results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco on October 27, 2025
DynamX® bioadaptor is the first interventional technology to demonstrate significant benefit with a reduction in long term adverse events in two consecutive randomized controlled trials
MILPITAS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) — Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced new landmark clinical results for its DynamX® bioadaptor, a coronary implant designed to restore a blood vessel’s natural movement and function, also known as hemodynamic modulation, demonstrating a 48% risk reduction in device-related cardiac events compared to current-generation drug-eluting stent.
The findings, presented on October 27th at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco, mark a major advance in coronary interventions after two decades of attempts to improve stenting outcomes.
The results show that the DynamX® bioadaptor achieved a 48% reduction in Target Lesion Failure (TLF) endpoint – encompassing reductions in cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization – from six months through two years (HR: 0.52 [0.29–0.93], p=0.027) in prespecified landmark superiority analysis.
Additional findings include:
- Significant reduction in Target Vessel Failure (TVF) (p=0.048) from six months through two years in prespecified landmark analysis.
- Substantial clinical benefit for high-risk patients with Acute Coronary Syndrome (ACS) (p=0.018) from six months through two years in prespecified landmark analysis.
“The INFINITY-SWEDEHEART long-term landmark results confirm our trial design hypothesis, demonstrating separation of the event curves for Target Lesion Failure (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 Principal Investigator David Erlinge, M.D., Ph.D., Head of the Cardiology Department at Lund University, Lund, Sweden.
The TCT presentation comes amid renewed global focus on rethinking coronary artery disease management. The recent Lancet Commission on rethinking coronary disease called for a paradigm shift from symptom-based treatment to earlier prevention and intervention, citing that cardiovascular disease affects roughly 19% of the global population and remains the world’s leading cause of death.
In addition to delivering the DynamX® bioadaptor’s impressive results, presentations from multiple leading physicians investigating and demonstrating successful clinical outcomes with Elixir Medical technologies garnered a heavy podium presence each day at the TCT Conference. From October 25th through the 28th, investigators are unveiling new clinical and case performance data regarding the company’s LithiX™ Hertz Contact Intravascular Lithotripsy (HC-IVL) device while leading the discussion on topics like Is It Time to Move Beyond Stents for Lasting Patient Outcomes? and The Rebirth of Novel Technologies for Coronary PCI.
As highlighted in a recent Wall Street Journal piece on physicians’ efforts to improve coronary artery disease treatment, in-stent restenosis and thrombosis after angioplasty (PCI) continue to drive repeat interventions and adverse outcomes despite widespread use of drug-eluting stents, adding to worsening long-term patient prognosis and significant healthcare costs. The DynamX® bioadaptor directly addresses these stent related issues by unlocking, adapting, and allowing the artery to heal and return to natural motion after fixated support is no longer needed: a key limitation of drug-eluting stents.
About DynamX® 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 reduction in plaque progression. 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 three-year clinical follow-up in BIOADAPTOR-RCT trial.
The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device in the United States limited by United States law to investigational use. The DynamX® Coronary Bioadaptor System is CE-mark approved.
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 and Fierce Medtech’s 2025 Fierce 15 list. Visit us at www.elixirmedical.com and on LinkedIn and X.
Media Contact
Richard Laermer
RLM PR
elixir@rlmpr.com
(212) 741-5106 X 216
