Elixir Medical, known for its innovative technologies in treating cardiovascular disease, has announced compelling late-breaking data showcasing the advantages of the DynamX® Coronary Bioadaptor System over the Resolute Onyx™ zotarolimus drug-eluting stent (DES) in reducing target lesion failure (TLF) among complex patient populations. This data, drawn from the INFINITY-SWEDEHEART randomized controlled trial (RCT), includes insights into patients with acute coronary syndrome (ACS), small vessel lesions, and lesions located in the left anterior descending (LAD) artery. The findings were presented at the Transcatheter Cardiovascular Therapeutics® (TCT®) annual symposium hosted by the Cardiovascular Research Foundation® (CRF®).
The data from the INFINITY-SWEDEHEART RCT has also been published in The Lancet, in a peer-reviewed article titled, “Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions – 12 months primary outcomes of the INFINITY-SWEDEHEART randomized non-inferiority trial.”
Dr. David Erlinge, M.D., Ph.D., the study’s principal investigator and head of the Cardiology Department at Lund University in Sweden, highlighted the challenges faced by patients with acute coronary syndrome (ACS), who often experience higher rates of adverse events post-percutaneous coronary intervention (PCI) due to comorbidities, reduced heart function, and overall frailty. He emphasized that analyzing this critical population was essential for understanding how the bioadaptor’s unique mechanism can enhance safety and efficacy following PCI. The study showed a sustained reduction in target lesion failure (TLF) rates after six months, further validating the significant clinical advantages of the bioadaptor for high-risk patients.
Key clinical results after six months for patients with ACS included:
- A TLF rate of 0.3% for the DynamX bioadaptor compared to 1.8% for the Resolute Onyx DES (p<0.018), representing an 83% reduction.
- Additional analysis of complex lesions, such as those in the left anterior descending (LAD) artery and small vessels, confirmed that the bioadaptor’s unique mechanism led to substantial clinical improvements over DES, aligning with findings from the BIOADAPTOR-RCT trial.
Specifically, patients with LAD lesions experienced a 73% reduction in TLF (0.2% vs. 2.2%) after six months with the DynamX bioadaptor. Notably, there were no TLF events in patients with small vessels (≤2.75 mm) treated with the bioadaptor, compared to a 1.8% rate in the DES group.
Motasim Sirhan, CEO and founder of Elixir Medical, remarked on the persistent challenges with traditional drug-eluting stents and bioresorbable scaffolds, which show an annual increase in adverse event rates of 2-3%, affecting 40-50% of patients within ten years. He expressed excitement over the validation of the bioadaptor’s novel mechanism, which aims to restore vessel function and offers a promising treatment option for patients with coronary artery disease (CAD).
The bioadaptor employs a unique mechanism that aims to restore vessel motion and function by unlocking its helical strands after six months, providing adaptive support that helps the vessel respond effectively to physiological demands. It has already been used to treat thousands of patients, with increasing physician expertise in complex PCI cases, including primary PCI, chronic total occlusions, bifurcations, and calcified lesions.
About the INFINITY-SWEDEHEART Trial
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor to a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. This trial is conducted in collaboration with the SWEDEHEART registry program in Sweden, a national initiative launched in 2009 aimed at advancing evidence-based therapies for heart disease. Study management is supported by Uppsala Clinical Research Center (UCR), a non-profit organization dedicated to enhancing healthcare through clinical research.
DynamX Coronary Bioadaptor System
The DynamX bioadaptor has been designated as a breakthrough device by the FDA and is the first coronary implant designed to restore coronary artery hemodynamic modulation. It demonstrates restored vessel pulsatility, compliance, and an adaptive increase in blood flow, while also stabilizing and regressing plaque. This unique mechanism addresses the limitations of traditional drug-eluting stents and bioresorbable scaffolds, leading to remarkably low clinical event rates that plateau after six months, as shown in the BIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2,400) trials.
The DynamX Coronary Bioadaptor System is CE-marked but is not yet approved for sale in the U.S.
