4-Year BIOADAPTOR RCT Data Presented for Elixir’s DynamX System 

May 28, 2026—Elixir Medical announced 4-year results from the BIOADAPTOR randomized controlled trial (RCT), which is comparing the company’s DynamX sirolimus-eluting coronary bioadaptor system to a standard-of-care drug-eluting stent (DES). The study randomized 445 patients 1:1 at 34 centers in Japan, Europe, and New Zealand. Clinical follow-up in the study will continue through 5 years, noted Elixir.

The DynamX system has received European CE Mark approval. It is not available for sale in the United States, advised the company.

The BIOADAPTOR RCT data were presented during a late-breaking clinical trial session at the EuroPCR 2026 conference in Paris, France.

According to the company, the 4-year results highlighted durable clinical outcomes with the DynamX bioadaptor, with no new target lesion failure (TLF) or cardiovascular death events observed between years 3 and 4, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES.

As summarized in the company’s press release, DynamX compared to the DES (Resolute Onyx zotarolimus DES; Medtronic) demonstrated a 66% lower rate of TLF (2.8% vs 7.8%; P = .02)—a reduction driven by improvement across all components of the device-related combined endpoint. The components include an 88% lower rate cardiovascular death (0.5% vs 3.7%; P = .02); numerically lower target vessel myocardial infarction (0.9% vs 1.8%); and numerically lower clinically driven target lesion revascularization (1.4% vs 2.8%).

These findings highlight that DynamX demonstrated stabilization of event rates after restoration of vessel function at 6 months postprocedure, whereas DES outcomes continue to accrue adverse events over time, noted Elixir.

Additionally, the company reported that clinical improvement was also observed in the left anterior descending artery, with lower TLF rates with DynamX compared to DES (2.7% vs 10.6%; P = .021). Elixir stated that this finding potentially reflects an amplified impact of restoring vessel function in this hemodynamically critical coronary vessel.

“The DynamX bioadaptor represents a significant advancement in percutaneous coronary intervention by providing functional restoration of the artery,” commented trial Principal Investigator Shigeru Saito, MD, in Elixir’s press release. “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.”

The DynamX system has received European CE Mark approval. It is not available for sale in the United States, advised the company.