Elixir Medical has completed subject enrolment in the BIOADAPTOR randomised controlled trial (RCT) of the DynamX Coronary Bioadaptor System.
The device is claimed to be the first drug-eluting coronary artery implant that is designed to adapt to vessel physiology.
It enables normal vessel functions restoration, which is important for cardiovascular performance.
The DynamX Bioadaptor aims to address the number of major adverse cardiac events that occur with drug-eluting stents (DES) every year without plateau.
The randomised, multicentre, single-blind BIOADAPTOR RCT recruited 444 subjects from 35 centres in New Zealand, Europe and Japan.
In this trial, subjects will be randomised and treated with the DynamX Bioadaptor and Resolute Onyx, a DES.
Target lesion failure (TLF) at one year will be the study’s primary endpoint.
The implant’s ability for vessel growth accommodation from disease progression, restoration of vessel pulsatility in an imaging subset and incidence of major cardiovascular events will be measured as some of the secondary endpoints of the trial.
BIOADAPTOR RCT principal investigator Shigeru Saito said: “The bioadaptor is a revolutionary innovation in percutaneous coronary intervention and we are enthusiastic about studying the device’s ability to accommodate and restore vessel movement and function.
“Despite the challenges presented by the Covid pandemic, we are proud that we were able to enrol the trial in about one year.”
Elixir Medical stated that the DynamX Bioadaptor enables the restoration of natural artery function, as well as movement, by including uncaging elements in its metallic implant design.
The device also helps to improve clinical outcomes by restoring positive adaptive remodelling, pulsatility and rotation while adapting to vessel physiology.