Elixir Medical’s DynamX Sirolimus-Eluting coronary bioadaptor system receives US FDA Breakthrough Device Designation

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Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, has announced that the company’s novel bioadaptive implant, DynamX^® Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the US.

The breakthrough designation is for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.

The DynamX bioadaptor has a novel design and mechanism of action designed to return the diseased vessel to a more normal condition, through three distinct phases. After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease (CAD). Unique to the bioadaptor, the second phase occurs after the bioadaptor is encapsulated with tissue and the absorbable polymer coating is resorbed. This enables the bioadaptor helical strands to unlock and separate, releasing and allowing the vessel to grow and adapt to maintain the established blood flow lumen. The third and most unique phase provides the vessel adaptive dynamic support by the separated helical strands. This restores the vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilisation and regression.