Nectero Medical has been awarded U.S. Food and Drug Administration (FDA) Fast Track designation for its Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm. Nectero Medical is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness. .

Nectero Medical因其Nectero血管内动脉瘤稳定治疗（Nectero EAST）系统获得美国食品和药物管理局（FDA）快速通道指定，用于治疗最大直径3.5-5.0cm的肾下AAA患者.Nectero Medical正在启动一项随机，对照II/III期临床试验（stAAAble）评估产品的安全性和有效性。。.

Fast Track designation offers significant advantages to companies developing novel technologies to treat unmet clinical needs. The designation allows for more frequent meetings with the FDA to ensure appropriate data collection in support of drug approval, enables eligibility for accelerated approval and priority review, and supports rolling review, where individual sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted once completed rather than waiting for the entire application to be reviewed. .

快速通道指定为开发新技术以治疗未满足的临床需求的公司提供了显着的优势。该名称允许与FDA进行更频繁的会议，以确保为支持药物批准而收集适当的数据，使其有资格获得加速批准和优先审查，并支持滚动审查，生物许可证申请（BLA）或新药申请（NDA）的各个部分可以在完成后提交，而不是等待整个申请进行审查。。.

Each year, FDA limits the Fast Track designation to only a select number of novel drugs that offer the potential to treat a serious disease. “This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to address a large segment of patients who suffer from a serious progressive disease with no proven treatment options.

每年，FDA都会将快速通道指定限制在某些提供治疗严重疾病潜力的新药上。“这一名称强化了Nectero Medical的信念，即Nectero EAST系统有可能解决大部分患有严重进行性疾病且没有经过证实的治疗选择的患者。

Available therapies are reserved primarily for patients who fall into the highest-risk category,” Nectero Medical President/CEO Jack Springer said. “We are proud to be advancing a treatment that has the potential to impact so many lives and are extremely pleased that FDA acknowledged this through our designation.” .

Nectero医疗总裁/首席执行官Jack Springer说，现有疗法主要用于风险最高的患者。“我们很自豪地推进一种可能影响如此多生活的治疗方法，并且非常高兴FDA通过我们的指定承认了这一点。”。.

The Nectero EAST System is a single-use, endovascular system used to treat infrarenal abdominal aortic aneurysms (AAA). More than 1 million Americans are living with AAA and about 60,000 undergo treatment each year; complications of AAA account for approximately 10,000 U.S. deaths annually. Available treatments are primarily reserved for AAAs larger than 5.0/5.5cm (female/male) in diameter, symptomatic patients, or rapidly expanding aneurysms.

Nectero EAST系统是用于治疗肾下腹主动脉瘤（AAA）的一次性血管内系统。超过100万美国人患有AAA，每年约有60000人接受治疗；AAA的并发症每年约有10000美国死亡。可用的治疗方法主要用于直径大于5.0/5.5cm（女性/男性）的AAAs，有症状的患者或快速扩张的动脉瘤。

Smaller AAAs are traditionally monitored with serial ultrasound or CT surveillance. Patients with small- and mid-sized aneurysms carry a .5-5% annual risk of rupture..

传统上，较小的AAA通过连续超声或CT监测进行监测。中小型动脉瘤患者每年有5-5%的破裂风险。。

The Nectero EAST System is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation.

Nectero EAST系统由双气囊输送导管和含有戊三酰葡萄糖（PGG）的稳定剂混合物组成。该系统将PGG局部递送到动脉瘤壁中，在那里它与弹性蛋白和胶原蛋白结合以增强主动脉血管壁并潜在地降低进一步降解的风险。

The procedure does not require any specialized tools, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST System may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.  .

该程序不需要任何专门的工具，只需不到一个小时即可完成，不会留下永久性植入物，也不排除任何未来的干预措施。如果成功，Nectero EAST系统可能会为AAAs较小的患者提供超出监测范围的首个批准的治疗选择。  .