DynamX Demonstrates 60% Lower Three-Year Target Lesion Failure Rate Compared to Medtronic's Coronary Stent in Head-to-Head Trial

May 24, 2025 10:30 CST Updated 10:30

Medtronic

Medical Device Manufacturer

Elixir MedicalThe three-year follow-up results of the BIOADAPTOR 1:1 Randomized Controlled Trial (RCT) were published. This is a randomized controlled trial involving34 centers in Japan, Europe, and New Zealand445 patients. The control group in this study selected Medtronic.Resolute Onyx. The study showed that in terms of target lesion failure (TLF) and cardiovascular death (CVD), the experimental group demonstrated a consistently low rate of adverse events and persistent clinical benefits, while the control group exhibited a non-plateauing upward trend in adverse events.

Specific Research Results

Significantly Reduce Device-Related Adverse Events: During the three-year follow-up, the incidence of device-related adverse events in the experimental group remained significantly lower than that in the control group (TLF rate:2.7% vs. 7.2%; p=0.030), confirming its long-term treatment efficacy.
Comprehensive Improvement in Composite Endpoints: The significant difference in TLF was driven by advantages across the individual endpoints, including lower cardiovascular mortality (0.5% vs. 3.2%, p=0.033), target vessel myocardial infarction rate (0.9% vs. 1.8%), and ischemia-driven target lesion revascularization rate (1.4% vs. 2.7%).
Left Anterior Descending Artery (LAD) Lesions Show More Significant Benefits: In the key areas of hemodynamics,DynamX reduces TLF rate for LAD lesions by 75% (2.7% vs. 10.6%; p=0.019), consistent with the "restoration of vascular function" mechanism revealed in the previous 12-month imaging sub-study.

PI Evaluation

"Three-year data from the BIOADAPTOR trial confirmed that DynamX has pioneered a completely new treatment paradigm --- its mechanism of action continues to provide clinical benefits after being activated 6 months post-implantation, even impacting hard endpoints such as cardiovascular death. The significant difference between the two groups in LAD lesions underscores the clinical importance of restoring hemodynamic regulation in this area."

---Shigeru Saito Shonan Kamakura General Hospital

Executive Evaluation

"Three-year RCT data and the 2400-patient INIFINITY-SWEDEHEART study published in The Lancet jointly confirm that DynamX demonstrated a significant and sustained plateau in clinical event curves as early as six months post-implantation. This consistency across multiple studies validates the clinical value of our revolutionary technology."

---Motasim Sirhan CEO of Elixir Medical

DynamX

DynamXIt is the first coronary stent designed to adapt to vascular physiology.DynamXIt is a coronary stent with a drug-eluting, bioabsorbable polymer coating that supports the coronary arteries during the healing process and has radial strength comparable to traditional stents.Drug-Eluting StentSimilar. AndTraditionalDrug-ElutingDifferent, after six months, the polymer coating dissolves,The stent structure can be loosened but maintains longitudinal continuity., allowing it to move freely with the natural expansion and contraction of the artery. This helps maintain active adaptive remodeling capacity, restore vascular function, and allow the vessel to return to its baseline angle.

DynamXThe stent is71um thickGulow alloy,The coating is biodegradable novomos.。

Comparison between DynamX and DES

DES

Traditional DES can open narrowed blood vessels, but may also make the lesion area become enclosed.This maintains the area of the blood vessel and stent, but as the disease continues to progress, the lumen area will decrease.

Dynamix

The adapter can also open narrow blood vessels while self-regulating remodeling, pulsatility, and the natural curvature and elasticity of arteries, potentially reducing adverse event reactions in the future. Normal coronary arteries expand in response to atherosclerosis or disease progression, a process known as positive adaptive remodeling, which slows disease progression and helps maintain blood flow and oxygen supply to the myocardium.It maintains the lumen area and good blood flow as the artery at the lesion site expands.

DynamX Demonstration

Elixir Medical

Elixir Medical A medical device company located in California, USA, developing next-generation platforms for the treatment of coronary artery and peripheral artery diseases, aiming to restore adaptive remodeling and pulsatile motion capabilities of blood vessels. Its mission is to transform care for patients with heart and vascular diseases through innovation.