The INFINITY-SWEDEHEART trial, a large-scale randomized controlled trial, has demonstrated that Elixir Medical's DynamX Coronary Bioadaptor System met its primary endpoint of target lesion failure (TLF) non-inferiority compared to the Resolute Onyx zotarolimus drug-eluting stent (DES) at 12 months (2.35% versus 2.77%; p<0.001). The results, presented at the European Society of Cardiology (ESC) Congress 2024, suggest a potential advancement in the treatment of coronary artery disease. The trial enrolled 2,400 patients, representing a complex patient population.
Key Findings from INFINITY-SWEDEHEART
The study revealed that the DynamX bioadaptor achieved TLF non-inferiority (p<0.001) at 12 months compared to the Resolute Onyx DES. Numerically lower adverse events drove the low TLF with DynamX across components of the composite endpoint:
- Target vessel myocardial infarction (TV-MI): 1.27% versus 1.52%
- Ischemia-driven target lesion revascularization (ID-TLR): 1.27% versus 2.11%
- Cardiovascular death: 0.59% versus 0.50%
Target vessel failure (TVF) at 12 months was also lower for DynamX compared to DES (3.03% versus 3.52%).
Landmark Analysis Highlights Long-Term Benefits
A pre-specified landmark analysis of TLF and TVF after six months demonstrated statistically significant reductions with DynamX:
- Statistically significant reduction in TLF with DynamX (0.2% versus 1.3%, p=0.003)
- Statistically significant reduction in TVF with DynamX (0.6% versus 1.8%, p=0.008)
These event rates were driven by reductions across all components of these composite endpoints.
Clinical Implications of Bioadaptor Technology
According to Dr. David Erlinge, M.D., Ph.D., Head of the Cardiology Department at Lund University, the DynamX bioadaptor represents a significant clinical advancement in treating coronary artery disease. He noted that while percutaneous coronary intervention (PCI) is generally safe, the implantation of stents has been associated with an annual recurring adverse event rate. The bioadaptor's potential to sustain reduction and plateauing of these recurring adverse clinical events could create a major benefit over a patient's lifetime.
Dr. Stefan James, M.D., Ph.D., Professor of Cardiology at Uppsala University, emphasized the potential of the Bioadaptor to significantly reduce the recurring adverse event risk after PCI in a population representative of everyday clinical practice. He attributed this to the Bioadaptor's unique design and mechanism of action in restoring hemodynamic modulation of a diseased artery.
DynamX Bioadaptor: Mechanism of Action
The DynamX bioadaptor has a novel mechanism of action designed to restore vessel health through three distinct phases:
- Locked phase: Establishes maximum flow lumen to restore blood flow.
- Unlocked/Separation phase: After six months, helical strands unlock and separate to allow adaptive remodeling of the vessel.
- Adaptive dynamic support phase: The three independent helical strands continue to provide essential support as the bioadaptor re-establishes vessel hemodynamic modulation through restoration of pulsatility, compliance, and adaptive blood flow volume.
Regulatory Status and Company Perspective
The DynamX bioadaptor has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The bioadaptor is CE-marked but not available for sale in the U.S.
Motasim Sirhan, CEO of Elixir Medical, stated that the INFINITY-SWEDEHEART trial results validate the consistency of low and plateauing adverse event rates after the bioadaptor's unlocking at six months, as previously shown in the BIOADAPTOR RCT and other studies. He expressed excitement about the landmark analysis data showing statistically significant reductions in TLF and TVF versus DES, further validating the bioadaptor’s unique mechanism of action and its advantage in treating coronary artery disease.
