Elixir Medical has announced three-year results from the 445-patient BIOADAPTOR 1:1 randomised controlled trial (RCT), comparing the DynamX coronary bioadaptor system to Resolute Onyx (Medtronic) drug-eluting stent (DES) from 34 centres in Japan, Europe, and New Zealand.
The results demonstrate sustained 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. The data were presented at a late-breaking clinical session during the 2025 EuroPCR congress (20–23 May, Paris, France).
Clinical results show sustained significant reduction of device-oriented adverse events with DynamX bioadaptor over the drug-eluting stent at three years, including a significant reduction in TLF rate (2.7% vs. 7.2%; p=0.030) demonstrating the durability of DynamX treatment through three years of follow-up.
The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX compared to DES, respectively, including significantly lower CVD (0.5% vs. 3.2%, p=0.033), target-vessel myocardial infarction (0.9% vs. 1.8%) and ischaemia-driven target lesion revascularisation (1.4% vs. 2.7%)
The reduction in adverse events was amplified in left anterior descending (LAD) artery lesions, with a significantly lower TLF rate in LAD lesions (2.7% vs. 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this haemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months.
“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 Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan). “We also see the heightened importance of restoring haemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.”
The DynamX bioadaptor has a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow.
After six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel haemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion, Elixir Medical says in a press release.
“With these results, we are pleased to demonstrate that restoring haemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,” said Motasim Sirhan, chief executive officer 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.”
