Elixir Medical officials have announced the novel bioadaptive implant, the DynamX Sirolimus-Eluting Coronary Bioadaptor System, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The designation is based on its capacity to decrease plaque progression, improve coronary luminal diameter, and restore hemodynamic modulation in patients with distinct de novo native coronary artery lesions causing symptomatic ischemic heart disease.
The DynamX bioadaptor features an innovative design and mechanism of action that aim to restore the diseased vessel to a more normal state through three distinct phases. Initially, after implantation, the locked phase establishes the maximum flow lumen and restores blood flow to alleviate the symptoms of coronary artery disease (CAD). Uniquely, in the second phase, after the bioadaptor is encapsulated with tissue and the absorbable polymer coating is resorbed, the helical strands unlock and separate, allowing the vessel to grow and adapt to maintain the established blood flow lumen.
The third and most unique phase provides adaptive dynamic support to the vessel through the separated helical strands. The phase restores vessel viability and hemodynamic modulation by reintroducing pulsatility, compliance, adaptive blood flow volume and plaque stabilization and regression.
The FDA Breakthrough Device Designation accelerates the review process for novel technologies that may offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as CAD, which affects 7.8% of the U.S. population.
Currently, interventional treatment of coronary artery disease with drug-eluting stents can establish flow angiographically. But within five years of treatment, up to 20% of patients had another implant-related adverse event.
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