– June 18, 2024 – Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced the company’s novel bioadaptive implant, DynamX® Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

–2024年6月18日–Elixir Medical是一家治疗心血管疾病的颠覆性技术开发公司，今天宣布该公司的新型生物适应植入物DynamX®西罗莫司洗脱冠状动脉生物适应系统已获得美国食品和药物管理局（FDA）的突破性设备指定。

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.

突破性的名称是指改善冠状动脉管腔直径，恢复血流动力学调节，并减少由于离散的新生冠状动脉病变引起的症状性缺血性心脏病患者的斑块进展。DynamX生物适配器具有新颖的设计和作用机制，旨在通过三个不同的阶段将患病血管恢复到更正常的状态。

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.

植入后，锁定相建立最大流量腔并恢复血流以治疗冠状动脉疾病（CAD）的症状。生物适配器独特的是，第二阶段发生在生物适配器被组织包裹并且可吸收聚合物涂层被再吸收之后。这使得生物适配器螺旋链能够解锁和分离，释放并允许血管生长并适应以维持已建立的血流腔。

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 stabiliz.

第三个也是最独特的阶段通过分离的螺旋链提供血管自适应动态支撑。这通过恢复搏动性，顺应性，适应性血流量和斑块稳定性来恢复血管活力和血流动力学调节。