FDA grants De Novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

FDA grants De Novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

Press releases may be edited for formatting or style | February 11, 2020 Cardiology Operating Room
SAN ANTONIO, Feb. 11, 2020 /PRNewswire/ -- Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. 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, MD, Interventional Radiologist at St. Joseph Hospital in Orange, California 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.

Servicing GE/Siemens Nuclear Medicine equipment with OEM trained engineers

Numed, a well established company in business since 1975 provides a wide range of service options including time & material service, PM only contracts, full service contracts, labor only contracts & system relocation. Call 800 96 Numed for more info.

"Thoracic central venous obstruction (TCVO) is a costly problem associated with increased patient morbidity and reduced quality of life," stated Bart Dolmatch, MD, Interventional Radiologist at The Palo Alto Medical Foundation. "We've 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."

You Must Be Logged In To Post A Comment