The BIOADAPTOR randomized controlled trial compared DynamX to the Medtronic Resolute Onyx DES, the current standard of care. It compared the therapies across Japan, Europe and New Zealand. Investigators shared findings from 445 patients at EuroPCR in Paris.
Results build on three-year findings shared at last year’s edition of EuroPCR.
Elixir said the four-year results highlight durable clinical outcomes with DynamX. Investigators reported no new target lesion failure (TLF) or cardiovascular death (CVD) events between years three and four. The system maintained a very low plateauing rate of adverse events, compared to a continued annual increase with DES.
More about the Elixir Medical DynamX bioadaptor
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 works in three distinct phases.
First, after implantation, the locked phase establishes the maximum flow lumen. That restores blood flow to treat symptoms of coronary artery disease (CAD). Unique to the bioadaptor, the second phase occurs after tissue encapsulates the device. This process resorbs the absorbable polymer coating and enables the helical strands to unlock and separate. That releases and allows the vessel to grow and adapt to maintain the established blood flow lumen.
The third phase provides the vessel adaptive dynamic support by the separated helical strands. This restores vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.
Elixir won FDA breakthrough device designation for DynamX in 2024. The system has CE mark but remains investigational in the U.S.
A look at the results shared at EuroPCR
DynamX demonstrated a 66% lower TLF rate (2.8% vs. 7.8%) compared to DES in the study. This reflected a significant clinical benefit and long-term durability of percutaneous coronary intervention (PCI) with a bioadaptor.
Investigators saw the TLF reduction driven by improvement across all components of the device-related combined endpoint.
Elixir reported 88% lower cardiovascular death (0.5% vs. 3.7%), marking a statistically significant reduction. It also saw numerically lower target vessel myocardial infarction (0.9% vs. 1.8%) and numerically lower clinically driven target lesion revascularization (1.4% vs. 2.8%).
The company says its findings highlight a key differentiation with the bioadaptor compared to DES, demonstrating stabilization of events. Investigators also saw substantial clinical improvement in the left anterior descending (LAD) artery. They reported dramatically lower TLF rates with DynamX (2.7% vs. 10.6%), potentially reflecting an amplified impact of restoring vessel function in the hemodynamically critical coronary vessel.
Commentary from company officials and study investigators
Motasim Sirhan, CEO of Elixir Medical, said:
“The four-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT have shown consistently across multiple randomized clinical trials significantly lower, plateauing clinical events with DynamX bioadaptor compared to DES treatment, demonstrating the clear benefit of restoring a key function of arteries, hemodynamic modulation, with this breakthrough technology.”
Dr. Stefan Verheye, interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium, and leading DynamX investigator, said:
“Interventional cardiologists typically use a drug-eluting stent (DES) during percutaneous coronary intervention (PCI) to open the heart blockage and keep the artery open. These interlocked mesh-like tubes, however, permanently cage the artery, limiting its function and contributing to an annual 2-3% increase in adverse clinical events over time. The bioadaptor is a new type of unlocking, adaptive implant designed to keep the artery open while restoring normal vessel function, its compliance and pulsatility.”
Dr. Shigeru Saito, trial principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, said:
“The DynamX bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery. Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.”
