Phraxis has announced the successful initiation of its post-approval study (PAS) for the EndoForce anastomotic connector, with the first procedure performed at Spartanburg Regional Healthcare System (Spartanburg, USA).
This milestone marks a significant transition from regulatory achievement to the establishment of long-term, real-world clinical utility, the company says in a press release.
The device was granted US Food and Drug Administration (FDA) approval midway through 2025. 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.
The EndoForce PAS is designed to validate real-world performance and refine procedural techniques associated with the device, specifically targeting the graft-to-vein outflow anastomosis—long considered the primary failure point in arteriovenous (AV) grafts.
The inaugural PAS procedure was performed by Ari Kramer, leading a multidisciplinary clinical team specialised in advanced vascular access.
“This milestone reflects our conviction that US Food and Drug Administration (FDA) approval is the foundation, not the finale, of a device’s clinical narrative,” said Alex Yevzlin, chief executive officer of Phraxis. “Through this study, we are upholding a rigorous commitment to transparency and evidence-based medicine, ensuring that the dialysis community has the longitudinal data necessary to improve patient outcomes.”
John Zentgraf, chief operating officer of Phraxis, adds: “This first PAS case represents disciplined progress—aligning clinical evidence generation with deliberate operational execution. In the medtech sector, durable innovation is built through this precise intersection of clinical rigor and scalable practice.”
