Elixir Medical has announced enrolment completion in INFINITY-SWEDEHEART, a prospective, multicentre, single-blind, randomised clinical trial of the DynamX coronary bioadaptor system, the first metallic coronary artery implant that adapts to vessel physiology versus the Resolute Onyx (Medtronic) drug-eluting stent (DES).
In a press release, Elixir Medical describes DynamX bioadaptor as 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 press release adds that 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 compared to DES in the treatment of patients with ischaemic 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 ischaemia-driven target lesion revascularisation (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 ischaemic heart disease and no advancements have been made to address the annual non-plateauing adverse events,” said David Erlinge (Lund University, Lund, Sweden), 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 Stefan James (Uppsala University Hospital, Uppsala, Sweden), chairman of the Swedeheart Steering Committee.
“We are thrilled to complete enrolment 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,” 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 stabilisation 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 DynamX bioadaptor clinical evidence programme consisting of nine company-sponsored and investigator-initiated studies enrolling more than 9,000 patients.
The DynamX Coronary Bioadaptor System is CE marked. The device is not available for sale in the USA.