The final patient has been enrolled in a study comparing Elixir Medical’s metallic coronary artery implant to Resolute Onyx’s drug-eluting stent (DES).
The multicentre, prospective, single-blind, randomised registry-based trial (NCT04562805) has enrolled 2,400 patients with ischemic heart disease across Sweden. The primary endpoint is target lesion failure (TLF) at a one-year follow up. This endpoint includes cardiovascular death, ischemia-driven target lesion revascularization (ID-TLR), and target vessel myocardial infarction (TV-MI). Patients will be followed for 2 to 5 years via clinical diagnostic registries.
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Elixir Medical’s implant, the DynamX Bioadaptor, has already been successfully compared to the Resolute Onyx in a previous trial involving 445 patients. The California, US-based company says the latest trial is designed to add further clinical data.
According to Elixir, DynamX Bioadaptor is “a new type of coronary implant designed to unlock the scaffold, uncage the vessel, to return normal vessel motion and function after percutaneous coronary intervention (PCI), with continued dynamic support of the atherosclerotic vessel to reduce long-term adverse events.” The implant’s scaffold is formed from three metallic helical strands joined by a thin bioresorbable polymer coating, which provides strength.
According to a market model by GlobalData, the coronary stent market is forecast to reach $5.3bn by 2033.
“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,” said Motasim Sirhan, Elixir Medical’s CEO.
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