FDA grants De Novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

FDA grants De Novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

Press releases may be edited for formatting or style | February 11, 2020 Cardiology Operating Room

Thoracic central venous obstruction occurs in roughly 40% of patients where hemodialysis is performed via a central venous catheter.1 While permanent arteriovenous fistulas are the preferred form of vascular access for hemodialysis patients, central venous catheters continue to serve as an important bridge to securing long-term access for life-saving hemodialysis treatment. The current approach for most patients with central venous obstructions is to use an alternative vein, which reduces the ability to place and mature a functioning fistula, resulting in increased catheter days and costs.

"We are thrilled 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," stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. "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 US."

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The Surfacer System will be available in select U.S. centers in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and Middle East.


About the Surfacer® Inside-Out® Access Catheter System
The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient's venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers. The Surfacer System is CE marked and distributed in Europe by Merit Medical, a global distributor of medical devices.


About Bluegrass Vascular Technologies
Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures.


SOURCE Bluegrass Vascular Technologies

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