Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the first patient has been treated in the BIOADAPTOR randomised controlled trial (RCT) of the DynamX coronary bioadaptor system. The first patient in the study was treated by Shigeru Saito, MD, director of the cardiology and catheterization laboratory at Shonan Kamakura General Hospital in Kanagawa, Japan and principal investigator of the study.
The BIOADAPTOR RCT is a multicentre, randomised single-blind study encompassing 444 patients in Japan, Germany and select other sites treated with the DynamX Bioadaptor in a 1:1 randomisation to Resolute Onyx (Medtronic). The primary endpoint of the study is target lesion failure at one year. Secondary endpoints include measures of the implant’s ability to accommodate vessel growth from disease progression and restore artery pulsatility in an imaging subset, as well as other major cardiovascular events. Saito is the principal investigator for the BIOADAPTOR RCT. Holger Nef, Universitätsklinikum Giessen, is the principal investigator in Germany.
The DynamX Bioadaptor is a metal implant with a drug-eluting bioresorbable polymer coating that supports the coronary artery during healing, with radial strength similar to DES. Over six months, the polymer coating dissolves, uncaging the bioadaptor and freeing the artery to move with the natural expansion and contraction of the artery, unlike DES. This has been shown to (a) maintain the ability for positive adaptive remodelling, (b) restore vessel function, and (c) allow for the vessel’s return towards baseline angulation.
“We are enthusiastic about leading this trial studying an important innovation in percutaneous coronary interventions, the bioadaptor,” said Saito. “By doing this clinical trial, we can scientifically test the safety and efficacy of this bioadaptor in a clinical situation for patients.”
“The DynamX Bioadaptor RCT is an important contribution to demonstrating the significant benefits our device offers for patients,” said Motasim Sirhan, Elixir Medical CEO. “Elixir’s DynamX Bioadaptor is the only technology designed to accommodate disease progression, improve blood flow to the heart and reduce stresses on the artery. By creating a coronary artery device that allows the restoration of normal vessel function, we expect to demonstrate safety and efficacy with a reduction in clinical events.”