Elixir Medical Begins BIOADAPTOR Trial of DynamX System

January 13, 2021—Elixir Medical announced that the first patient has been treated in the BIOADAPTOR randomized controlled trial (RCT) of the DynamX coronary bioadaptor system, a drug-eluting coronary artery implant that adapts to vessel physiology.

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. Dr. Saito is Principal Investigator of the BIOADAPTOR study.

“We are enthusiastic about leading this trial studying an important innovation in percutaneous coronary interventions, the bioadaptor,” commented Dr. Saito in the announcement. “By doing this clinical trial, we can scientifically test the safety and efficacy of this bioadaptor in a clinical situation for patients.”

According to the company, the BIOADAPTOR RCT is a multicenter, randomized, single-blind study composed of 444 patients in Japan, Germany, and select other sites. Patients will be treated with the DynamX bioadaptor in a 1:1 randomization to Resolute Onyx drug-eluting stent (DES; Medtronic). Professor Holger Nef, MD, of Universitätsklinikum Giessen in Giessen, Germany, is the trial’s principal investigator in Germany.

The primary endpoint of the study is target lesion failure at 1 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.

Elixir Medical stated that 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 6 months, the polymer coating dissolves, uncaging the bioadaptor and freeing the artery to move with the natural expansion and contraction of the artery. This has been shown to maintain the ability for positive adaptive remodeling, restore vessel function, and allow for the vessel’s return toward baseline angulation.

The DynamX bioadaptor has received European CE Mark approval. It is not available for sale in the United States.