Phraxis Inc.

普拉克西斯公司

, a

，一个

Minneapolis

明尼阿波利斯

-based medical device company, marks a major milestone with FDA approval of the

基于医疗设备的公司，FDA批准标志着一个重要的里程碑。

EndoForce™ Connector for Endovascular Venous Anastomosis (EndoForce™)

EndoForce™ 血管内静脉吻合连接器 (EndoForce™)

— a pivotal development in the evolution of dialysis access technology.

——透析通路技术发展中的一个关键转折点。

EndoForce™

安多力™

is a patented endovascular implant designed to simplify and modernize the creation of arteriovenous grafts (AVGs) for hemodialysis. The device enables a unique endovascular anastomosis, eliminating the need for surgical dissection of the venous anastomosis and promoting precise, coaxial vessel-to-graft alignment.

是一种获得专利的血管内植入物，旨在简化和现代化血液透析用动静脉移植物 (AVGs) 的创建。该装置能够实现独特的血管内吻合，无需进行静脉吻合的外科解剖，并促进精确的同轴血管与移植物对齐。

EndoForce™ is engineered to reduce tissue trauma, streamline procedural workflow, and support long-term graft performance..

EndoForce™ 旨在减少组织损伤、简化手术流程并支持长期移植性能。

John Ross

约翰·罗斯

, MD, lead principal investigator for the pivotal study,

医学博士，关键研究的首席主要研究者，

commented:

评论：

'I'm excited to see the EndoForce™ provide a novel anastomotic option for AVG creation. This straightforward and innovative approach enhances procedural efficiency while addressing key challenges in vascular access. Its unique design has the potential to reduce complications such as intimal hyperplasia at the graft-to-vein anastomosis, ultimately supporting improved long-term outcomes for dialysis patients.'.

“我很高兴看到EndoForce™为 AVG 创建提供了一种新颖的吻合选择。这种简单而创新的方法提高了手术效率，同时解决了血管通路的关键挑战。其独特的设计有潜力减少移植物与静脉吻合处内膜增生等并发症，最终有助于改善透析患者的长期预后。”

The device is compatible with standard 6mm ePTFE AVGs and incorporates several proprietary elements: anchoring barbs that secure the device within the vein; a flexible, ePTFE-covered nitinol segment that conforms to the graft and vessel wall; and a compressible section that expands securely within the AVG upon deployment.

该设备与标准的6毫米ePTFE人造血管移植物兼容，并包含了多个专有元件：固定倒钩，可将设备固定在静脉内；一个柔性的、覆盖ePTFE的镍钛诺段，能够贴合移植物和血管壁；以及一个在展开时可在人造血管移植物内安全扩展的可压缩部分。

This configuration supports a stable, end-to-end anastomosis intended to promote laminar blood flow and reduce turbulent shear stress—factors that contribute to endothelial buildup and graft failure..

这种配置支持稳定、端到端的吻合，旨在促进层流血流并减少湍流剪切应力——这些因素会导致内皮堆积和移植物失败。

In a pivotal, multicenter, single-arm study, EndoForce™ achieved procedural success, meeting its primary endpoint of cumulative patency at six months, with a 92% patency rate. Secondary endpoints—including primary patency and technical success—further reinforced the device's strong clinical performance..

在一项关键的多中心单臂研究中，EndoForce™ 实现了手术成功，达到了六个月累计通畅率的主要终点，通畅率为 92%。次要终点（包括初始通畅率和技术成功）进一步证实了该设备出色的临床表现。

Alexander Yevzlin

亚历山大·叶夫兹林

, MD, CEO of Phraxis Inc.,

，医学博士，Phraxis Inc.首席执行官，

stated:

声明：

'FDA approval of the EndoForce™ Connector marks a major advancement for the dialysis community. The device introduces a new standard for AVG creation and has demonstrated exceptional ease of use and procedural reliability. While long-term outcomes are still being evaluated, we remain optimistic about its potential to improve dialysis care.'.

“EndoForce™ 连接器获得FDA批准标志着透析界的一项重大进步。该设备为AVG创建引入了新标准，并展现出卓越的易用性和程序可靠性。虽然长期结果仍在评估中，我们对其改善透析护理的潜力保持乐观。”

The EndoForce™ Connector is now available to healthcare providers and clinicians, offering an innovative, minimally invasive solution for patients with end-stage renal disease (ESRD). Phraxis remains committed to supporting the successful integration of EndoForce™ into clinical practice and enabling providers to deliver improved, durable dialysis access outcomes..

EndoForce™ 连接器现已向医疗保健提供者和临床医生推出，为晚期肾病（ESRD）患者提供了一种创新的、微创的解决方案。Phraxis 仍致力于支持 EndoForce™ 成功融入临床实践，使提供者能够实现改善且持久的透析通路效果。

About Phraxis Inc.

关于Phraxis公司

Based in

总部位于

Minneapolis, MN

明尼阿波利斯，明尼苏达州

, Phraxis Inc. is a medical device company committed to advancing vascular access technologies for patients with end-stage renal disease (ESRD). Through innovative solutions like the EndoForce™ Connector for Endovascular Venous Anastomosis, Phraxis is focused on improving patient care by addressing critical challenges in dialysis access and delivering durable, long-term solutions for ESRD patients worldwide..

Phraxis Inc. 是一家医疗设备公司，致力于为终末期肾病 (ESRD) 患者推进血管通路技术。通过像 EndoForce™ 内血管静脉吻合连接器这样的创新解决方案，Phraxis 专注于通过解决透析通路中的关键挑战来改善患者护理，并为全球 ESRD 患者提供持久的长期解决方案。