FDA Grants Breakthrough Status to Elixir Medical's DynamX Coronary Bioadaptor for Ischemic Heart Disease

Elixir Medical, a company known for developing groundbreaking cardiovascular disease treatments, has announced a significant milestone. Their innovative bioadaptive implant, the DynamX® Sirolimus-Eluting Coronary Bioadaptor System, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation is aimed at improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients suffering from symptomatic ischemic heart disease due to new, native coronary artery lesions.

The DynamX bioadaptor is unique in its design and functionality, aiming to revert the diseased artery to a more normal condition through three distinct phases. Initially, the locked phase of the bioadaptor establishes the maximum flow lumen, thereby restoring blood flow to mitigate symptoms of coronary artery disease (CAD). Once the bioadaptor is encapsulated in tissue and its absorbable polymer coating is resorbed, it transitions to the second phase. Here, the helical strands of the bioadaptor unlock and separate, allowing the vessel to expand and adapt to preserve the established blood flow lumen. In the third and final phase, the separated helical strands provide adaptive dynamic support, restoring the vessel's viability and hemodynamic modulation. This phase is particularly significant as it reinstates vessel pulsatility, compliance, adaptive blood flow volume, and stabilizes and regresses plaque.

The FDA’s Breakthrough Device Designation is designed to expedite the review process for innovative technologies that could provide more effective treatments for life-threatening or irreversibly debilitating conditions, such as CAD, which affects 7.8% of the U.S. population. Traditionally, drug-eluting stents have been used for the interventional treatment of CAD, but approximately 20% of patients experience repeat adverse events related to the implant within five years.

Motasim Sirhan, CEO of Elixir Medical, emphasized the need for a more innovative approach to restore vessel viability. He highlighted that “caging” the vessel with stents was previously considered the main factor for the annual increase in non-plateauing event rates. However, data from bioresorbable scaffold technologies indicated that non-plateauing event rates continue even after the scaffold resorbs, necessitating a new solution like the DynamX bioadaptor.

Sirhan also expressed gratitude for the FDA’s recognition of the bioadaptor technology and looked forward to collaborating with the FDA, Centers for Medicare & Medicaid Services, and physician societies to bring this technology to U.S. patients soon. He acknowledged the support of the Invus Group, Elixir Medical’s financial partners, for their unwavering commitment to the company's mission.

Recent two-year clinical trial data presented at EuroPCR 2024 showed that the DynamX bioadaptor significantly outperformed the standard of care, Resolute Onyx™ Drug-Eluting Stent (DES). The trial revealed a 65% reduction in Target Lesion Failure (TLF) rate for patients treated with the bioadaptor compared to those treated with DES. The reduction was driven by lower adverse events across all components of the composite endpoint for DynamX. The effect was even more pronounced in critical left anterior descending (LAD) artery vessels, showing a 78% reduction in TLF rate with DynamX compared to DES. These findings build on 12-month results demonstrating the superiority of DynamX in imaging endpoints, including lower percentage diameter stenosis, late lumen loss, and improved measures of vessel pulsatility, compliance, and adaptive blood flow.

The DynamX Coronary Bioadaptor System is CE-marked and is the first coronary implant technology designed to restore coronary artery hemodynamic modulation by reestablishing vessel pulsatility, compliance, adaptive blood flow volume, and stabilizing and regressing plaque. Although it is not yet available for sale in the U.S., its unique mechanism of action addresses the limitations of drug-eluting stents and bioresorbable scaffolds, as evidenced by remarkably low clinical event rates that plateau between one-year and two-year clinical follow-up.

Elixir Medical Corporation, based in Milpitas, California, is a privately held company focused on developing disruptive platforms to treat coronary and peripheral artery disease. Their technologies offer potential applications across the cardiovascular field, promising improved clinical outcomes for millions of patients.