, /PRNewswire/ -- Phraxis Inc., a Minneapolis-based medical device company, marks a major milestone with FDA approval of the EndoForce™ Connector for Endovascular Venous Anastomosis (EndoForce™) — a pivotal development in the evolution of dialysis access technology.

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

John Ross, MD, lead principal investigator for the pivotal study, commented:
"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."

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. 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.

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.

Alexander Yevzlin, MD, CEO of Phraxis Inc., stated:
"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."

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.

About Phraxis Inc.

Based in Minneapolis, MN, 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.

For more information:
www.phraxis.com

SOURCE Phraxis Inc.