Elixir Medical’s DynamX Studied at 3 Years in BIOADAPTOR RCT

May 30, 2025—Elixir Medical recently announced 3-year results from the BIOADAPTOR randomized controlled trial (RCT) comparing the company’s DynamX coronary sirolimus-eluting bioadaptor system to the standard-of-care Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic). The study was composed of 445 patients enrolled at 34 centers in Japan, Europe, and New Zealand.

According to the company, the results demonstrated sustained low adverse events and durability of clinical outcomes with the DynamX bioadaptor in terms of target lesion failure (TLF) and cardiovascular death (CVD) compared to a nonplateauing increase in adverse events in the DES arm.

The BIOADAPTOR RCT data were presented in a late-breaking clinical session at the EuroPCR 2025 conference held May 20-23 in Paris, France.

As summarized in Elixir’s press release, the 3-year BIOADAPTOR RCT results showed a significant reduction in the TLF rate for the DynamX system versus the DES (2.7% vs 7.2%; P = .03).

The company noted that the reduction in TLF with DynamX compared to DES was driven by low adverse events across all components of the composite endpoint: CVD (0.5% vs 3.2%, P = .033); target vessel myocardial infarction (0.9% vs 1.8%); ischemia-driven target lesion revascularization (1.4% vs 2.7%).

Additionally, the reduction in adverse events was amplified in left anterior descending (LAD) artery lesions with a significantly lower TLF rate in LAD lesions for DynamX compared to DES (2.7% vs 10.6%; P = .019), reported Elixir.

The company stated that this reduction was consistent with the bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months (Saito et al. The Lancet eClinicalMedicine; 2023;65:102304).

Shigeru Saito, MD, serves as rincipal investigator of the BIOADAPTOR RCT. Dr. Saito is director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan.

“These 3-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from 6 months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,” commented Dr. Saito in the company’s press release. “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.”

The DynamX coronary bioadaptor system has received CE Mark approval. In the United States, it is an investigational device limited by Federal law to investigational use, advised Elixir Medical.