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.
“This trial is conducted through a robust national Swedeheart registry and includes patients we typically see in our practices, with both chronic and acute coronary syndromes, and will provide important data to potentially change the future of PCI treatment,” commented Professor Stefan James, Uppsala University Hospital and Chairman of the Swedeheart Steering Committee.
“We are thrilled to complete enrollment of INFINITY-SWEDEHEART as we continue building a world-class body of clinical evidence that supports the DynamX Bioadaptor as the best treatment for patients living with coronary artery disease (CAD),” said Motasim Sirhan, CEO of Elixir Medical. “INFINITY-SWEDEHEART gives us the opportunity to evaluate Bioadaptor use in more diverse patient populations, further reinforcing the remarkable results from our BIOADAPTOR RCT trial data that, at 12 months, showed statistically significant effectiveness in restoring vessel pulsatility, as well as novel findings of plaque stabilization and regression. We look forward to assessing the bioadaptor data coming out of INFINITY-SWEDEHEART with this large, real-world patient population.”
INFINITY-SWEDEHEART is the fourth trial of Elixir Medical’s robust DynamX Bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies enrolling more than 9,000 patients.
About the INFINITY-SWEDEHEART Trial
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is part of the ongoing Swedeheart registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for coronary heart disease.
About DynamX Coronary Bioadaptor Scaffold
DynamX Bioadaptor is the first coronary scaffold technology designed to unlock the scaffold, uncage the vessel, and restore and sustain normal vessel motion and function after PCI by maintaining dynamic support of the diseased vessel after its uncaging. With this unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) while delivering low clinical event rates.
The DynamX Coronary Bioadaptor System is CE marked. Not available for sale in the U.S.