Gabriele Niederauer, Ph.D.

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… Continue reading.

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… Continue reading.

Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access, today announced the enrollment of its first patients in the SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial. The SAVE-US clinical trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Surfacer® Inside-Out® Access Catheter System to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. Thirty patients will be enrolled at up to 10 centers in the United States with additional centers in Europe.

Initial patient enrollments were performed by Interventional Radiologists Chris Loh, MD, and Mahmood Razavi, MD, at St. Joseph Hospital in Orange, California and by Eric Peden, MD, a Vascular Surgeon at Houston Methodist Hospital in Houston, Texas… Continue reading.