Elixir Medical has announced four-year results from the large 445-patient BIOADAPTOR randomised controlled trial (RCT) comparing the DynamX coronary bioadaptor system to the standard-of-care Resolute Onyx (Medtronic) drug-eluting stent (DES) at 34 centres in Japan, Europe, and New Zealand. The data were presented at a late-breaking clinical trial session during EuroPCR 2026 (19–22 May, Paris, France).
“Interventional cardiologists typically use a 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,” said Stefan Verheye (ZNA Cardiovascular Center, Antwerp, Belgium), leading DynamX investigator. “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.”
Late-breaking four-year results presented at EuroPCR highlight durable clinical outcomes with the DynamX bioadaptor, with no new target lesion failure (TLF) or cardiovascular death (CVD) events observed between years three and four, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES.
DynamX demonstrated a 66% lower TLF rate compared to DES (2.8% vs 7.8%, respectively; p=0.02), reflecting significant clinical benefit and long-term durability of PCI treatment with the bioadaptor. The TLF reduction was driven by improvement across all components of the device-related combined endpoint, including 88% lower cardiovascular death (0.5% vs 3.7%; p=0.02), a statistically significant reduction; numerically lower target vessel myocardial infarction (0.9% vs 1.8%); and numerically lower clinically driven target lesion revascularisation (1.4% vs 2.8%).
According to Elixir, these findings highlight a key differentiation of the bioadaptor implant from DES: while DES outcomes continue to accrue adverse events over time, DynamX demonstrates stabilisation of event rates following restoration of vessel function at six months post-procedure.
Substantial clinical improvement was also observed in the left anterior descending (LAD) artery, with TLF rates dramatically lower with DynamX compared to DES (2.7% vs 10.6%, respectively; p=0.021), potentially reflecting an amplified impact of restoring vessel function in this haemodynamically critical coronary vessel responsible for about 50% of heart blood supply.
“The DynamX bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery,” remarked trial principal investigator Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan). “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.”
Elixir notes that PCI procedures have been successful at improving the conductance of blood through diseased, blocked coronary arteries. Stents establish luminal diameter and improve the acute mechanical result of PCI compared to balloon angioplasty. However, a DES does not restore the physiology of the vessel wall because it creates rigid scaffolding. This constrains vessel elasticity and prevents return to a more normal, pulsatile function.
The DynamX bioadaptor first achieves the initial objective of opening the artery in establishing luminal diameter to improve blood flow. Unlike a DES, it transitions to a different structure following an initial period of healing where it unlocks and provides the essential radial dynamic support to the diseased artery, allowing the treated segment to recover pulsatility and compliance.
“The four-year BIOADAPTOR RCT data, and the results from the 2,400-patient INIFINITY-SWEDEHEART RCT, have shown consistently—across multiple randomised 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, haemodynamic modulation, with this breakthrough technology,” commented Elixir CEO Motasim Sirhan.
