Elixir’s Dynamx Coronary Bioadaptor System Submitted for Approval in Japan

October 4, 2023—Elixir Medical announced the company’s Dynamx coronary bioadaptor system for the treatment of coronary artery disease has been submitted to Japan’s Pharmaceutical and Medical Device Agency for approval. Currently, the Dynamx coronary bioadaptor system has received CE Mark approval in Europe. It is not available for sale in the United States.

According to the company, the Dynamx coronary implant is designed to unlock the scaffold, uncage the vessel, and provide essential dynamic support after uncaging to return normal vessel motion and function after percutaneous coronary intervention. The device was developed to overcome the limitations of drug-eluting stents (DESs) and bioresorbable scaffolds.

Elixir Medical noted that in a randomized controlled trial versus DESs, the Dynamx system’s mechanism of action has shown reduced target lesion failure rates and restored vessel pulsatility, translating to increased blood flow, improved vessel lumen diameter, and reduced plaque progression.

Shigeru Saito, MD, director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, is the principal investigator of the BIOADAPTOR randomized controlled trial (RCT).

The international, single-blinded, randomized controlled (1:1) trial is comparing the Dynamx sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (Resolute Onyx; Medtronic) in 445 patients. Both arms included a large randomized multi-imaging modality subgroup of 100 patients powered to document standard effectiveness benchmarks and the new effectiveness benchmarks of vessel motion and function.

The company noted that the primary and secondary endpoints from the BIOADAPTOR RCT were presented at a late-breaking trial session at the EuroPCR conference held May 16-19 in Paris, France.

“DESs have served an important role in the treatment of coronary artery disease, but have yet to overcome many challenges, including restricting vessel motion and function, mechanical failure, and progression of plaque,” commented Dr. Saito in the company’s press release. “What we have seen with the Dynamx in the 12-month BIOADAPTOR RCT data exceeded our expectations against the current standard of care—the Resolute Onyx DES—in clinical outcomes, and for the first time ever demonstrated restoration of vessel pulsatility, motion, and function by uncaging the vessel while providing the needed support after uncaging. The findings collectively point to a technology standard not seen before that I believe is of great benefit to patients.”

The BIOADAPTOR RCT trial is the third trial of Elixir Medical’s Dynamx bioadaptor clinical evidence program involving more than 9,000 patients. The INFINITY SWEDEHEART RCT (n=2400) completed enrollment in July. The global BIO-RESTORE registry has a target enrollment of up to 5,000 patients.