Phraxis Unveils FDA-Approved EndoForce™ Connector for Dialysis Access Innovation

Phraxis Inc. Achieves FDA Approval for EndoForce™ Connector for Enhanced Dialysis Access

In a groundbreaking development for the medical device industry, Phraxis Inc., a company rooted in Minneapolis, has received FDA approval for its innovative EndoForce™ Connector. This advanced technology is set to revolutionize the landscape of dialysis access by streamlining the creation of arteriovenous grafts (AVGs) for patients requiring hemodialysis.

The EndoForce™ Connector stands out due to its patented design, which simplifies the process of creating an endovascular anastomosis. This significant innovation eliminates the traditional need for surgical dissection of the venous anastomosis. In doing so, it fosters a precise alignment between the vessels and grafts, thus minimizing tissue trauma and enhancing procedural workflow. The primary intention behind this development is to support long-term graft performance, an essential aspect in the treatment of patients suffering from end-stage renal disease (ESRD).

Dr. John Ross, the lead investigator in the pivotal study associated with EndoForce™, is enthusiastic about its potential. He noted, "The EndoForce™ offers a fresh and efficient method for AVG creation, addressing long-standing challenges in vascular access. Its novel design not only improves procedural efficiency but also aims to reduce complications like intimal hyperplasia at the graft-to-vein connection. This improvement could lead to better long-term outcomes for dialysis patients."

The EndoForce™ Connector is designed to work seamlessly with standard 6mm ePTFE AVGs. It features several proprietary components, including anchoring barbs that help secure the device within the vein, along with a flexible, ePTFE-covered nitinol segment that adapts to both the graft and vessel wall. Additionally, a unique compressible section ensures stability after deployment, promoting uninterrupted laminar blood flow and diminishing the risk of turbulent shear stress. Such factors are critical as they play a role in preventing endothelial buildup and subsequent graft failure.

Results from a multicenter, single-arm study demonstrated the effectiveness of the EndoForce™ Connector, achieving a remarkable 92% patency rate at the six-month mark, thus meeting its primary endpoint. Its performance in secondary endpoints—including primary patency and technical success—further underscored its efficacy in real-world applications.

Phraxis Inc.'s CEO, Dr. Alexander Yevzlin, emphasized the importance of this FDA approval, stating, "The EndoForce™ Connector represents a pivotal leap forward for the dialysis community. With this device, we are not only setting a new benchmark for AVG creation but also showcasing exceptional reliability and user-friendliness. While we continue to monitor long-term outcomes, we are optimistic about its capacity to enhance dialysis care."

Healthcare providers are now able to access the EndoForce™ Connector, a vital tool to aid patients with ESRD. The device aims to facilitate minimal invasion and promote durable dialysis access outcomes, reinforcing Phraxis’s commitment to improving healthcare through its innovative technologies.

About Phraxis Inc.

Headquartered in Minneapolis, MN, Phraxis Inc. is dedicated to advancing vascular access technologies that benefit patients suffering from ESRD. The company focuses on delivering impactful solutions like the EndoForce™ Connector to address pressing challenges in dialysis access, ultimately striving to improve patient care and outcomes on a global scale.

For additional details, please visit www.phraxis.com.