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Gabriele Niederauer, Ph.D.

AIMBE College of Fellows Class of 2012
For the development of novel biomedical devices of significant commercial value.

FDA grants de novo clearance for vascular access device

Via Healio | February 13, 2020

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.

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Bluegrass Vascular Announces Enrollment Of First Patients In U.S. Pivotal Trial

Via Bluegrass Vascular | January 18, 2018

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.

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