Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial
-Largest randomized trial of DynamX Bioadaptor to date with 2,400 patients enrolled, covering real-world population-
Excerpt from the Press Release:
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of breakthrough cardiovascular technologies, today announced enrollment completion in INFINITY-SWEDEHEART, a prospective, multicenter, single-blind, randomized clinical trial of the DynamX® Coronary Bioadaptor System, the first metallic coronary artery implant that adapts to vessel physiology versus the Resolute Onyx™ Drug-Eluting Stent (DES).
DynamX Bioadaptor is the next-generation coronary implant designed to unlock the scaffold, uncage the vessel, to return normal vessel motion and function after percutaneous coronary intervention (PCI), with sustained dynamic support of the atherosclerotic vessel to reduce long-term adverse events. The INFINITY-SWEDEHEART trial will further build on the body of evidence demonstrated in the successful BIOADAPTOR RCT comparing DynamX Bioadaptor to Resolute Onyx in 445 patients and will evaluate the safety and efficacy of the DynamX Bioadaptor compared to DES in the treatment of patients with ischemic heart disease in a broader patient population.
The trial includes 2,400 patients from 14 sites across Sweden. The primary Device Oriented Clinical Endpoint is target lesion failure (TLF); a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). Secondary endpoints include testing for superiority in reduction of TLF and angina pectoris with the bioadaptor over DES in all patients and in prespecified subgroups.
“For more than 20 years, generations of drug-eluting stents have offered no hard clinical benefits beyond the first year for the treatment of ischemic heart disease and no advancements have been made to address the annual non-plateauing adverse events,” said Professor David Erlinge, Lund University and principal investigator of the INFINITY-SWEDEHEART RCT.
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