Elixir Medical, a developer of cardiovascular treatments, announced that its DynamX Coronary Bioadaptor System has met the primary endpoint in the INFINITY-SWEDEHEART randomised controlled trial (RCT).
The DynamX Coronary Bioadaptor is said to be the first coronary implant designed to restore coronary artery haemodynamic function.
Its mechanism overcomes the limitations of traditional drug-eluting stents (DES) and bioresorbable scaffolds.
Elixir Medical has demonstrated its performance in both the BIOADAPTOR-RCT and INFINITY-SWEDEHEART trials.
The US Food and Drug Administration (FDA) granted breakthrough status to DynamX Coronary Bioadaptor in June. The technology has also received a CE mark.
The INFINITY-SWEDEHEART trial compared the system with Medtronic’s contemporary Resolute Onyx zotarolimus DES in 2,400 patients. The one-year primary outcomes from the study were unveiled last month,
The trial was conducted in partnership with the SWEDEHEART registry programme, a national research initiative established Sweden in 2009.
Clinical results revealed that the DynamX bioadaptor achieved a target lesion failure (TLF) rate of 2.35% compared to 2.77% for the Resolute Onyx DES, meeting the criteria for non-inferiority at 12 months.
The lower TLF with the bioadaptor was attributed to fewer adverse events in the individual components of the composite endpoint.
Specifically, the rates for target vessel myocardial infarction (TV-MI) were 1.27% for DynamX versus 1.52% for Resolute Onyx DES.
Additionally, ischemia-driven target lesion revascularisation (ID-TLR) was 1.27% versus 2.11%, and cardiovascular death was 0.59% versus 0.50%.
The target vessel failure (TVF) rate at 12 months was also lower with DynamX compared to the DES.
Furthermore, a landmark analysis conducted at six months demonstrated a statistically significant reduction in both TLF and TVF with the DynamX bioadaptor.
The TLF rate was significantly lower for coronary implants compared to Resolute Onyx DES, and the TVF rate was also significantly lower.
Elixir Medical CEO Motasim Sirhan said: “Results from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we’ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies – consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months.”
Elixir Medical develops advanced platforms to address coronary and peripheral artery disease. Its portfolio includes the DynamX BTK, LithiX Hertz Contact IVL, and TRx site-specific antithrombotic therapy.
