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.”
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