Elixir Medical has reported positive findings from a clinical trial investigating its company’s DynamX Coronary Drug-Eluting Bioadaptor compared to a popular drug-eluting stent device already approved for market. The findings, which show the device measures favourably to the Resolute Onyx stent system, were presented at the EuroPCR 2023 conference in Paris.
In the international, single-blinded, randomized controlled (1:1) trial (BIOADAPTOR RCT), 445 patients were tested to compare Elixir’s bioadaptor against Resolute Onyx stent system. The DynamX Bioadaptor was non-inferior to Resolute Onyx in target lesion failure (TLF) at 12 months – 1.8% compared to 2.8%. The company reported no cardiac deaths and low rates of vessel myocardial infarction.
DynamX showed restorative vessel pulsatility effectiveness, ability to maintain an open lumen and low late lumen loss. According to the company it is the first time, in the coronary revascularisation implant field, that a bioadaptor scaffold has demonstrated normal pulsatility.
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 scaffold itself is formed from three metallic helical strands joined by a thin bioresorbable polymer coating to provide strength.
“The DynamX Bioadaptor exceeded our expectations against a good DES in clinical outcomes, and for the first time ever demonstrated restoration of vessel pulsatility, motion and function by uncaging the vessel,” said Shigeru Saito, M.D., principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan.
“These findings establish that the bioadaptor addresses the shortcomings of DES and bioresorbable scaffolds, and collectively point to a technology effectiveness standard not seen before. The finding of plaque changes is very exciting, pointing to a new effect and potential benefit of restoring vessel function.”