FDA grants de novo clearance to Bluegrass Vascular for Surfacer system

1785
SAVE-US trial
Surfacer Inside-Out (Bluegrass Vascular)

Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novo classification order for its Surfacer Inside-Out access catheter system. The Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. The Surfacer system employs a novel Inside-Out approach.

“The Surfacer system offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites,” stated Mahmood Razavi, interventional radiologist at St. Joseph Hospital in Orange, USA and lead principal investigator of the SAVE-US (Surfacer system to facilitate access in venous Occlusions—United States) IDE study. “This is an unmet clinical need for patients who require life-saving therapies, such as dialysis, and who have limited options due to venous obstructions.”

The Surfacer system is the first FDA cleared medical device to facilitate upper body central venous access in patients with venous obstructions or other conditions that preclude access by conventional methods. Approval is based on the results of the SAVE-US trial. Of the thirty enrolled patients, 90% met both the primary and secondary efficacy endpoints despite a complex patient population comprised largely of Type 3 and 4 obstructions (3 or more obstructed vessels). No device related adverse events were reported, confirming the safety and performance of the Surfacer system.

“Thoracic central venous obstruction (TCVO) is a costly problem associated with increased patient morbidity and reduced quality of life,” stated Bart Dolmatch, interventional radiologist at The Palo Alto Medical Foundation (Palo Alto, USA). “We have recently published reporting standards that create a common language for understanding and describing signs, symptoms, functional impairment, and anatomy of TCVO. BVT incorporated elements of these reporting standards into the SAVE-US trial, demonstrating the clinical impact of the Surfacer system. Now that it has been FDA cleared, the Surfacer will be part of the treatment algorithm for my patients with TCVO.”

Thoracic central venous obstruction occurs in roughly 40% of patients where haemodialysis is performed via a central venous catheter. While permanent arteriovenous fistulas are the preferred form of vascular access for haemodialysis patients, central venous catheters continue to serve as an important bridge to securing long-term access for life-saving haemodialysis treatment. The current approach for most patients with central venous obstructions is to use an alternative vein, which reduces the ability to place and mature a functioning fistula, resulting in increased catheter days and costs.


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