Elixir Medical Submits Application to Japan's PMDA for DynamX® Coronary Bioadaptor System

Recently, Elixir Medical, a technology company specializing in the development of disruptive cardiovascular technologies, announced that it has submitted an application for regulatory approval of the DynamX® Coronary Bioadaptor System to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The system is designed for the treatment of coronary artery disease (CAD).

The DynamX Coronary Bioadaptor System was developed to overcome the limitations of drug-eluting stents (DES) and bioresorbable scaffolds (BRS). DynamX is a novel coronary implant designed to unlock the stent, unseal the vessel, and provide necessary dynamic support after percutaneous coronary intervention (PCI), restoring normal vascular motion and function. In randomized controlled trials with DES, its unique mechanism of action reduced target lesion failure (TLF) rates, restored vascular pulsatility, increased blood flow, improved lumen diameter, and decreased plaque progression.

Elixir Medical CEO Motasim Sirhan stated, "Our submission for approval in Japan represents an exciting milestone for both the company and the industry. The DynamX Coronary Bioadaptor is the culmination of significant design and manufacturing breakthroughs as well as three clinical trials, which consistently demonstrated that, compared to standard treatment, the DynamX Coronary Bioadaptor exhibits distinct functional performance. It has been over 20 years since there has been substantial innovation in treating coronary artery disease with stents. We are thrilled to challenge the current standard of care and bring our technology to doctors and patients worldwide."

Drug-eluting stents (DES) have played a significant role in the treatment of coronary artery disease, but many challenges still need to be overcome, including restricted vascular movement and function, mechanical failure, and plaque progression. The clinical outcomes of DynamX observed in the 12-month data from the BIOADAPTOR RCT exceeded expectations for the current standard of care (Resolute Onyx™ DES). These findings collectively indicate an unprecedented technological standard, which I believe will bring substantial benefits to patients.

The DynamX Coronary Bioadaptor System is the first coronary implant technology designed to unlock the stent, free the vessel, and restore the continuous natural movement and function of the vessel by providing dynamic support to the diseased vessel after unlocking post-PCI. With this unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) while demonstrating an extremely low rate of clinical events. The DynamX Coronary Bioadaptor System has received CE certification.

The DynamX™ Drug-Eluting Coronary Bioadaptor System is a significant innovation in the field of coronary artery disease treatment. DynamX surpasses drug-eluting stents (DES) and represents one of the most important breakthroughs in implant design over the past 30 years.

DynamX is the first coronary artery implant that adapts to vascular physiology in the following ways:

• Maintain a Positive Adaptive Remodeling Ability

• Restore Vascular Function

• Allow restoration to baseline angle

• Vascular motion loss caused by DES is associated with major adverse cardiac events (MACE).

BIOADAPTOR RCT is an international single-blind randomized controlled trial (1:1) that compared the sirolimus-eluting bioadaptor system with contemporary zotarolimus-eluting stents in 445 patients. Both arms of the trial included a large randomized multi-imaging modality subgroup of 100 patients, which was capable of documenting standard efficacy benchmarks as well as new efficacy benchmarks for vasomotion and functionality. The primary and secondary endpoints were presented during the late-breaking trial session at the EuroPCR 2023 conference.

The BIOADAPTOR RCT trial is the third trial in Elixir Medical's robust clinical evidence program for the DynamX Bioadaptor System, which consists of multiple clinical trials involving more than 9,000 patients, including the INFINITY SWEDEHEART RCT (n=2400) that completed enrollment in July, and the global BIO-RESTORE registry targeting up to 5,000 enrolled patients.

Elixir Medical Corporation is a privately held company headquartered in California, dedicated to developing disruptive platforms for the treatment of coronary and peripheral artery diseases. Its technology has various applications in the cardiovascular field, improving clinical outcomes for millions of patients.

The technical views in this article do not represent the views of CCI.

Planning: Shen Li/Editor: Chen Baolin

Author: Yin Anyuan /Production: Wang Rui