Elixir Medical, a developer of innovative cardiovascular technologies, announced that the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) has met its primary endpoint. The trial compared the novel DynamX® Coronary Bioadaptor System with the Resolute Onyx™ zotarolimus drug-eluting stent (DES), showing non-inferiority in target lesion failure (TLF) rates (2.35% vs. 2.77%; p<0.001) at 12 months. The findings were presented as a late-breaking session at the European Society of Cardiology (ESC) Congress 2024 in London.
“The DynamX bioadaptor marks a major advancement in treating coronary artery disease with a unique mechanism of action that benefits patients long after the percutaneous coronary intervention (PCI) procedure,” said Dr. David Erlinge, principal investigator and head of Cardiology at Lund University, Sweden. “While PCI is generally safe, stent implantation can lead to recurring adverse events. Reducing and stabilizing these events would greatly benefit patients over their lifetimes.”
Key results from the 2,400-patient INFINITY-SWEDEHEART study include:
- TLF Rates: DynamX bioadaptor and Resolute Onyx DES showed TLF rates of 2.35% and 2.77%, respectively, meeting non-inferiority (p<0.001) at 12 months.
- Adverse Events: DynamX bioadaptor showed numerically lower rates of target vessel myocardial infarction (1.27% vs. 1.52%), ischemia-driven target lesion revascularization (1.27% vs. 2.11%), and cardiovascular death (0.59% vs. 0.50%) compared to DES.
- Target Vessel Failure (TVF): TVF rates were 3.03% for the DynamX bioadaptor versus 3.52% for DES.
Landmark analysis after six months indicated:
- A statistically significant reduction in TLF (0.2% vs. 1.3%, p=0.003) and TVF (0.6% vs. 1.8%, p=0.008) with DynamX compared to DES.
“These results highlight the clinical impact of the Bioadaptor in treating coronary artery disease, with the potential to significantly reduce adverse event risk post-PCI,” said study chair Dr. Stefan James, Professor of Cardiology at Uppsala University. “The Bioadaptor’s unique mechanism of action, which restores hemodynamic modulation, sets it apart from traditional stents.”
The DynamX bioadaptor was recently granted FDA Breakthrough Device Designation to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease. Its unique mechanism involves three distinct phases:
- Locked Phase: Establishes maximum flow lumen to restore blood flow.
- Unlocked/Separation Phase: After six months, the helical strands unlock and separate, allowing adaptive remodeling to maintain blood flow.
- Adaptive Dynamic Support Phase: The independent strands provide essential support, restoring vessel hemodynamic modulation through improved pulsatility, compliance, and adaptive blood flow.
“INFINITY-SWEDEHEART trial results validate the bioadaptor’s unique mechanism of action, showing consistent low and plateauing adverse event rates after the unlocking phase at six months,” said Motasim Sirhan, CEO of Elixir Medical. “These data further confirm the bioadaptor’s advantage in treating coronary artery disease and enhancing patient care.”
About the INFINITY-SWEDEHEART Trial
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1) clinical trial comparing a sirolimus-eluting bioadaptor with a zotarolimus-eluting stent (DES) in 2,400 patients. The trial is part of the SWEDEHEART registry program in Sweden, supported by Uppsala Clinical Research Center (UCR) to advance heart disease treatments.
About the DynamX Coronary Bioadaptor System
The DynamX bioadaptor, CE-marked but not yet available in the U.S., is the first coronary implant designed to restore coronary artery hemodynamic modulation, showing low clinical event rates that plateau after six months in trials. It aims to address the limitations of drug-eluting stents and bioresorbable scaffolds.
About Elixir Medical
Elixir Medical, based in Milpitas, California, develops disruptive technologies for coronary and peripheral artery disease, offering innovative solutions to improve clinical outcomes for millions of patients worldwide.
