The 445-patient BIOADAPTOR trial compares DynamX to the standard of care Medtronic Resolute Onyx drug-eluting stent (DES). It took place across 34 centers in Japan, Europe and New Zealand. Data — shared this week at EuroPCR 2025 in Paris — adds to positive outcomes reported last fall.
Results demonstrated very low adverse events and durability of clinical outcomes with DynamX in target lesion failure (TLF) and cardiovascular death (CVD) compared to non-plateauing increase in adverse events in the DES arm.
Elixir said the significant reduction in TLF rate (2.7% vs. 7.2%) demonstrated the durability of DynamX through three years. Cardiovascular death came in at 0.5% in the DynamX arm vs. 3.2% in the DES arm. Investigators reported low target vessel myocardial infarction (0.9% vs. 1.8%) and ischemia-driven target lesion revascularization (1.4% vs. 2.7%).
Additionally, the study showed significatly lower TLF rates in left anterior descending (LAD) artery lesions (2.7% vs. 10.6%). This proves consistent with the bioadaptor mechanism of action of restoring vessel function.
“These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,” said Dr. Shigeru Saito, director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.”
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 last year. The system has CE mark but remains investigational in the U.S.
“With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,” said Motasim Sirhan, CEO of Elixir Medical. “With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX bioadaptor compared to DES, validating the benefit of our transformative technology.”
