Elixir Medical Successfully Completes Enrollment for the INFINITY-SWEDEHEART Clinical Trial
Friday, July 14, 2023
Elixir Medical, a leading developer of cardiovascular technologies, has announced the completion of participant enrollment for the INFINITY-SWEDEHEART clinical trial. This prospective, multicenter, single-blind, randomized trial aims to evaluate the efficacy and safety of the DynamX® Coronary Bioadaptor System developed by Elixir Medical.
The DynamX Bioadaptor System is an innovative metallic coronary artery implant designed to adapt to vessel physiology, unlike traditional drug-eluting stents (DES) such as the Resolute Onyx™. Its unique design aims to restore normal vessel motion and function after percutaneous coronary intervention (PCI) while providing ongoing support to the atherosclerotic vessel, thus reducing long-term adverse events.
The INFINITY-SWEDEHEART trial seeks to expand upon the promising results demonstrated in the previous BIOADAPTOR RCT study, which involved 445 patients and compared the DynamX Bioadaptor to the Resolute Onyx DES. By including a larger patient population with ischemic heart disease, the trial aims to gather further evidence regarding the safety and effectiveness of the DynamX Bioadaptor.
This clinical trial is conducted within the Swedeheart registry, a national collaborative research program established in 2009 to facilitate the development of evidence-based therapies for coronary heart disease. With a sample size of 2,400 patients, the INFINITY-SWEDEHEART trial is a prospective, multicenter, single-blind, randomized study comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES).
The trial includes patients with both chronic and acute coronary syndromes, providing valuable data that may potentially influence the future of PCI treatment. Elixir Medical's commitment to advancing cardiovascular care is demonstrated through this comprehensive clinical investigation.