MILPITAS, Calif.--(BUSINESS WIRE)--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).

加利福尼亚州米尔皮塔斯（商业新闻短讯）--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器系统已获美国食品和药物管理局（FDA）授予突破性设备称号。

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..

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。。

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).

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。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。

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.

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 stabilization and regression..

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，适应性血流量以及斑块稳定和消退来恢复血管活力和血流动力学调节。。

FDA Breakthrough Device Designation accelerates the review process for novel technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as CAD, which impacts 7.8% of the U.S. population.1

FDA突破性的设备指定加速了新技术的审查过程，这些新技术可以更有效地治疗或诊断威胁生命或不可逆转的衰弱疾病或病症，如影响7.8%美国人口的CAD。1

To date, interventional treatment of coronary artery disease with drug-eluting stents has been able to establish flow angiographically. However, up to 20% of patients experience a repeat adverse event related to the implant within five years of treatment.2

迄今为止，使用药物洗脱支架进行冠状动脉疾病的介入治疗已经能够通过血管造影建立血流。然而，高达20%的患者在治疗的五年内经历了与植入物相关的重复不良事件。2

“For many years, it was thought that caging of the vessel with stents was the main driver for annual increasing non-plateauing event rates. However, the data with the ‘leave nothing behind’ approach with bioresorbable scaffold technologies, showed non-plateauing event rates continue to occur even after resorption of the scaffold, so we needed a more innovative approach to restore vessel viability,” said Motasim Sirhan, CEO of Elixir Medical.3.

Elixir Medical首席执行官莫塔西姆·西汉（Motasim Sirhan）表示：“多年来，人们认为用支架固定血管是每年非平稳事件发生率增加的主要驱动因素。然而，使用生物可吸收支架技术的“不留痕迹”方法的数据显示，即使在支架被吸收后，非平稳事件发生率仍在继续发生，因此我们需要一种更具创新性的方法来恢复血管活力。”。

“We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology,” continued Sirhan. “We look forward to working with FDA, Centers for Medicare & Medicaid Services, and respective physician societies to bring this technology to U.S. patients as soon as possible to elevate the standard of care for cardiovascular disease treatment.”.

“我们非常感谢FDA对生物适应技术的突破性指定认可，”Sirhan继续说道。“我们期待着与FDA、医疗保险和医疗补助服务中心以及各自的医师协会合作，尽快将这项技术带给美国患者，以提高心血管疾病治疗的护理标准。”。

“The Elixir team is honored to partner with the Invus Group, our financial partners. We are grateful for their unwavering commitment and support of our mission throughout the years,” continued Sirhan.

“Elixir团队很荣幸与我们的财务合作伙伴Invus Group合作。我们感谢他们多年来对我们使命的坚定承诺和支持，”Sirhan继续说道。

Late-breaking two-year BIOADAPTOR RCT data presented at EuroPCR 20244 demonstrated a statistically significant benefit of DynamX bioadaptor over the standard of care, Resolute Onyx™ Drug-Eluting Stent (DES), where in patients treated for de novo lesions (per protocol patient population analysis), there was a 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046) respectively.

EuroPCR 20244上提供的迟发性两年生物适应器RCT数据显示，DynamX生物适应器比标准护理Resolute Onyx™药物洗脱支架（DES）具有统计学上的显着益处，其中在接受从头病变治疗的患者中（按方案患者人群分析），TLF率分别降低了65%（1.9%比5.5%；p=0.046）。

This reduction was driven by lower adverse events across all components of the composite endpoint for DynamX. In the critical left anterior descending (LAD) artery vessels the effect was even more pronounced with a 78% reduction (1.9% vs. 8.7%; p=0.028) in the TLF rate with DynamX bioadaptor versus DES.

这种减少是由于DynamX复合终点所有组成部分的不良事件较低所致。在关键的左前降支（LAD）动脉血管中，DynamX bioadaptor与DES相比，TLF率降低了78%（1.9%比8.7%；p=0.028），效果更为明显。

These data follow the 12-month results showing superiority over DES in imaging endpoints including lower % diameter stenosis, late lumen loss, and the new measures of vessel pulsatility, compliance and adaptive blood flow by restoring hemodynamic modulation and vessel viability.5.

这些数据遵循12个月的结果，显示优于DES的成像终点，包括较低的直径狭窄率，晚期管腔丢失，以及通过恢复血流动力学调节和血管活力来测量血管搏动性，顺应性和适应性血流的新方法。

DynamX Coronary Bioadaptor System

DynamX冠状动脉生物适应系统

The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and providing plaque stabilization and regression. With a unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds demonstrated by remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow-up..

DynamX生物适配器是第一种旨在恢复冠状动脉血流动力学调节的冠状动脉植入技术，如血管搏动性，顺应性，血流量适应性增加以及斑块稳定和消退所证明的。凭借独特的作用机制（MOA），它解决了药物洗脱支架和生物可吸收支架的缺点，这些支架的临床事件发生率非常低，在一年和两年的临床随访中表现出平稳。。

The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S.

DynamX冠状动脉生物适配器系统带有CE标记。不可在美国销售。

About Elixir Medical

关于Elixir Medical

Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease that include DynamX BTK, LithiX Hertz Contact IVL and TRx site-specific antithrombotic therapy. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients.

Elixir Medical Corporation是一家总部位于加利福尼亚州米尔皮塔斯的私营公司，它开发了用于治疗冠状动脉和外周动脉疾病的破坏性平台，包括DynamX BTK，LithiX Hertz Contact IVL和TRx位点特异性抗血栓治疗。我们的技术在心血管领域有多种应用，能够为数百万患者提供改善的临床结果。