Bluegrass Vascular Technologies (BVT) has announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. A press release reports that 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 system, according to the press release, employs a novel Inside-Out approach.
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 30 enrolled patients, 90% met both the primary and secondary efficacy endpoints despite a complex patient population comprised largely of type 3 and 4 obstructions (three or more obstructed vessels). No device related adverse events were reported, confirming the safety and performance of the Surfacer system.
Bart Dolmatch (The Palo Alto Medical Foundation, Palo Alto, USA) comments: “Thoracic central venous obstruction is a costly problem associated with increased patient morbidity and reduced quality of life. We have recently published reporting standards that create a common language for understanding and describing signs, symptoms, functional impairment, and anatomy of Thoracic central venous obstruction. 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 Thoracic central venous obstruction.”
Gabriele Niederauer, CEO and president of Bluegrass Vascular, notes: “We are thrilled BVT has reached this important milestone. For the first time ever, physicians in the US can offer patients a reliable and repeatable solution to treat central venous obstructions and restore access to the right internal jugular vein—the preferred access site. Through our experience in Europe and other international sites, the Surfacer system has consistently demonstrated a positive clinical impact. We are eager to bring the Surfacer system and its important benefits to patients in the USA.”
The Surfacer system will be available in select US centres in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and Middle East.