Phraxis Inc. has achieved a major milestone with FDA approval of its EndoForce™ Connector, a breakthrough endovascular device designed to modernize arteriovenous graft (AVG) creation for dialysis patients. Unlike traditional surgical methods that require venous dissection, EndoForce™ enables a minimally invasive endovascular venous anastomosis, simplifying the procedure while preserving tissue integrity. This patented innovation offers coaxial alignment between the graft and vein, improving procedural precision and potentially reducing complications that commonly affect long-term dialysis access.

The device incorporates several proprietary features including anchoring barbs for secure placement, a nitinol segment covered in ePTFE for optimal vessel and graft conformity, and a compressible region that expands to ensure stability within the AVG. This design promotes laminar blood flow, minimizing turbulent shear stress—one of the main contributors to endothelial buildup and graft failure. In a pivotal multicenter clinical trial, EndoForce™ achieved a 92% six-month patency rate, meeting primary efficacy endpoints and demonstrating strong procedural success and reliability across patient cases.

The FDA approval of EndoForce™ marks a significant advancement in vascular access for patients with end-stage renal disease (ESRD). By offering a less invasive, technically efficient alternative to surgical AVG creation, Phraxis is helping to improve patient outcomes, reduce procedural risks, and streamline dialysis access. The company is now focused on supporting clinicians in integrating this technology into practice, setting a new standard in dialysis care and reaffirming its commitment to innovation in vascular health.

MedTech Spectrum's Summary

Minimally Invasive Innovation : The EndoForce™ Connector enables endovascular creation of arteriovenous grafts (AVGs) without surgical dissection, reducing tissue trauma and simplifying dialysis access procedures.

Improved Clinical Outcomes : With a 92% six-month patency rate in clinical trials, the device promotes laminar blood flow and helps minimize complications like intimal hyperplasia, supporting long-term graft performance.

New Standard in Dialysis Access : FDA approval positions EndoForce™ as a game-changing solution for patients with end-stage renal disease, offering safer, more efficient dialysis access and advancing vascular care worldwide.