Elixir Medical announced compelling three-year results from its BIOADAPTOR randomized controlled trial, demonstrating sustained clinical superiority of the DynamX coronary bioadaptor system over standard drug-eluting stents. The data, presented at EuroPCR 2025 in Paris, showed significantly lower adverse event rates that plateaued after six months, suggesting a fundamentally different therapeutic approach to coronary intervention.
Trial Design and Patient Population
The BIOADAPTOR trial enrolled 445 patients across 34 centers in Japan, Europe, and New Zealand in a single-blind, randomized controlled design comparing the sirolimus-eluting DynamX bioadaptor to Medtronic's Resolute Onyx zotarolimus-eluting stent. The international scope and robust patient population provide strong evidence for the bioadaptor's clinical performance across diverse populations.
Primary Clinical Outcomes
The three-year results revealed sustained significant reductions in device-oriented adverse events with the DynamX bioadaptor. Target lesion failure (TLF) rates remained significantly lower at 2.7% versus 7.2% for drug-eluting stents (p=0.030), demonstrating durability of the treatment effect through extended follow-up.
Most notably, cardiovascular death rates showed a striking difference, with the bioadaptor group experiencing 0.5% mortality compared to 3.2% in the drug-eluting stent arm (p=0.033). This hard clinical endpoint provides compelling evidence for the bioadaptor's clinical benefit beyond traditional efficacy measures.
Additional components of the composite endpoint favored the bioadaptor, including target vessel myocardial infarction (0.9% vs 1.8%) and ischemia-driven target lesion revascularization (1.4% vs 2.7%).
Enhanced Benefits in Critical Vessel Locations
The clinical advantages were amplified in left anterior descending (LAD) artery lesions, where the bioadaptor achieved a TLF rate of 2.7% compared to 10.6% for drug-eluting stents (p=0.019). This finding aligns with the bioadaptor's mechanism of restoring vessel function in hemodynamically critical coronary vessels.
"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, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan.
Novel Mechanism of Action
The DynamX bioadaptor represents a paradigm shift from conventional stent technology through its three-phase adaptive mechanism. Initially, the device functions like a traditional stent, opening the artery and restoring blood flow. After six months, the bioadaptor unlocks and separates into three helical strands, releasing the vessel while providing dynamic support to maintain the established lumen.
This unique design enables restoration of vessel hemodynamic modulation, including pulsatility and adaptive blood flow volume, while demonstrating evidence of plaque stabilization and regression. The approach addresses fundamental limitations of both drug-eluting stents and bioresorbable scaffolds.
Broader Clinical Evidence Program
The BIOADAPTOR trial represents one component of Elixir Medical's comprehensive clinical evidence program encompassing nine studies involving over 9,000 patients. This includes the 2,400-patient INFINITY-SWEDEHEART RCT published in The Lancet and the ongoing global BIO-RESTORE registry targeting up to 5,000 patients.
"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. "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."
Regulatory Status and Future Directions
The DynamX Coronary Bioadaptor System currently holds CE marking for European markets, while remaining investigational in the United States under FDA oversight. Clinical follow-up for the BIOADAPTOR trial will continue through five years, providing additional long-term safety and efficacy data.
The sustained clinical benefits observed through three years, particularly the plateau in adverse events after six months, suggest the bioadaptor's mechanism may fundamentally alter the natural history of treated coronary lesions compared to conventional stent technology.
