FDA grants de novo clearance for vascular access device
The FDA has granted a de novo classification order to Bluegrass Vascular Technologies for its Surfacer Inside-Out Access Catheter System. The device was designed to enable central venous access in patients with venous obstructions, according to a press release.
“The Surfacer system offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites,” Mahmood Razavi, MD, an interventional radiologist at St. Joseph Hospital in Orange, California, and lead principal investigator of the Surfacer System to Facilitate Access in Venous Occlusions – United States (SAVE-US) IDE study, said in the release. “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.”
According to the release, the approval follows SAVE-US trial results that found 90% of enrolled patients — most of whom had three or more obstructed vessels — met both the primary and secondary efficacy endpoints. Furthermore, no device-related adverse events were reported.
The system is the first of its kind to be cleared by the FDA.
“We are thrilled [Bluegrass Vascular Technologies] BVT has reached this important milestone. For the first time ever, physicians in the U.S. 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,” Gabriele Niederauer, PhD, CEO and president of Bluegrass Vascular, said. “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 U.S.”