FDA Approves Phraxis EndoForce Connector for Endovascular Venous Anastomosis

May 22, 2025—Phraxis Inc. announced FDA approval of the EndoForce connector for endovascular venous anastomosis for dialysis access in patients with end-stage renal disease.

According to the company, the endovascular EndoForce implant is designed to simplify the creation of arteriovenous grafts (AVGs) for hemodialysis. By enabling an endovascular anastomosis, the device promotes precise coaxial vessel-to-graft alignment and eliminates the need for surgical dissection of the venous anastomosis, noted Phraxis.

Additionally, the company stated that the device is intended to reduce tissue trauma, streamline procedural workflow, and support long-term graft performance. It is compatible with standard 6-mm expanded polytetrafluoroethylene AVGs.

In the multicenter, single-arm pivotal study of EndoForce, the device achieved procedural success and met its primary endpoint of cumulative patency at 6 months, with a 92% patency rate. Secondary endpoints—including primary patency and technical success—further reinforced the device’s clinical performance, noted the company.

John Ross, MD, served as lead Principal Investigator for the pivotal study.

“I’m excited to see the EndoForce provide a novel anastomotic option for AVG creation,” commented Dr. Ross in the company’s press release. “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.”