#United States #Spartanburg #Vascular Access #Phraxis Inc #EndoForce Connector

Phraxis Inc. Launches First Post-Approval Study with EndoForce™ Connector

Phraxis Inc., a leading medical device company, announced a pivotal step in advancing vascular access technology by initiating its first Post-Approval Study (PAS) for the EndoForce™ Anastomotic Connector. The first procedure took place at Spartanburg Regional Healthcare System, marking a significant transition from regulatory approval to real-world clinical application.

Understanding the Importance of Post-Approval Studies

Post-approval studies are essential for medical devices, as they generate evidence beyond controlled settings to ascertain the effectiveness and reliability of a device in everyday clinical practice. The PAS for the EndoForce is aimed at validating real-world performance and enhancing procedural techniques specifically focused on the graft-to-vein outflow anastomosis. This anastomosis has historically posed challenges and represents a primary point of failure in arteriovenous (AV) grafts.

The Inaugural Procedure

The first procedure was performed by Dr. Ari Kramer, who led a multidisciplinary clinical team specializing in advanced vascular access. Dr. Kramer’s insight into the clinical nuances of using the EndoForce could significantly influence the device's adoption in standard practices.

Commitment to Transparency and Evidence-Based Medicine

Alex Yevzlin, MD, Chief Executive Officer of Phraxis, stated, "This milestone reflects our conviction that FDA approval is the foundation, not the finale, of a device's clinical narrative." This perspective emphasizes the company's dedication to transparency in reporting the outcomes of the PAS, ensuring the dialysis community has comprehensive data to enhance patient outcomes.

John Zentgraf, Chief Operating Officer of Phraxis, echoed these sentiments by describing the first PAS case as disciplined progress that harmonizes clinical evidence generation with practical execution. This systematic approach is vital for ensuring that innovative technologies are both clinically effective and operationally sustainable.

Looking Forward

Phraxis aims to boost the durability of vascular access through diligent partnerships and data-informed strategies. The company views the initiation of this study as the catalyst for a broader cycle of generating clinical evidence which, in turn, supports the widespread adoption of the EndoForce™ Connector as a new standard of care in vascular access for hemodialysis patients.

About Phraxis Inc.

Phraxis Inc. is committed to transforming outcomes in vascular access for patients undergoing hemodialysis. The EndoForce™ Anastomotic Connector is specifically engineered to address the complexities associated with AV graft failures, focusing on enhancing graft longevity and improving overall patient quality of life.

For media inquiries, please contact:
Geoffrey Beecher
Chief Commercial Officer, Phraxis Inc.
Email: [email protected]

This ongoing commitment to patient care and device innovation positions Phraxis Inc. at the forefront of medical advancements in vascular access.