Elixir Medical Reports INFINITY-SWEDEHEART Met 12-Month Primary Endpoint

September 2, 2024—Elixir Medical announced that the INFINITY-SWEDEHEART randomized controlled trial (RCT), which is evaluating the company’s DynamX coronary bioadaptor system with the Resolute Onyx zotarolimus drug-eluting stent (DES), met its 12-month primary endpoint of target lesion failure (TLF) noninferiority (2.35% vs 2.77%; P < .001). 

The data were presented as part of a late-breaking session at the European Society of Cardiology Congress in London, England, United Kingdom.

“The DynamX bioadaptor represents a significant clinical advancement in the treatment of coronary artery disease (CAD) with a unique mechanism of action 6 months following the percutaneous coronary intervention (PCI) procedure,” commented David Erlinge, MD, in the company’s announcement. Dr. Erlinge is the Principal Investigator of the trial and head of the Cardiology Department at Lund University, Lund, Sweden.

According to the company, the low TLF was impacted by a lower target vessel myocardial infarction (1.27% vs 1.52%), ischemia-driven target lesion revascularization (1.27% vs 2.11%), and comparable rate of cardiovascular death (0.59% vs 0.50%). Target vessel failure at 1 year was also lower for DynamX compared with the DES (3.03% vs 3.52%).

“The results of our trial strongly support the clinical impact of the bioadaptor in CAD treatment, with a potential to significantly reduce the recurring adverse event risk after PCI in a population representative of everyday clinical practice,” said study chair Stefan James, MD, in Elixir’s announcement. “The Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery.”  Dr. James is Professor of Cardiology at Uppsala University, Sweden.

Earlier this year, the DynamX coronary bioadaptor system was granted Breakthrough Device designation by the FDA with ​​an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. It is not commercially available in the United States but has received CE Mark approval. 

INFINITY-SWEDEHEART is a prospective, multicenter, single-blind, registry-based RCT evaluating data from 2,400 patients. The trial is partnered with Sweden’s ongoing SWEDEHEART registry.