May 15, 2020
Bluegrass Vascular Announces First US Surfacer Inside-Out Catheter Commercial Cases
May 15, 2020—Bluegrass Vascular Technologies announced the introduction of the Surfacer Inside-Out access catheter system.
The first commercial cases in the United States using the Surfacer Inside-Out system were performed by Ehab Sorial, MD, and Ajit Nair, MD at Santa Clara Valley Medical Center in San Jose, California. The device was used to obtain venous access in two hemodialysis patients with central venous obstructions, one of whom had limited access options.
"We are excited to be the first program in the United States to incorporate use of the Surfacer system into our day-to-day clinical practice," commented Dr. Nair and Dr. Sorial in the company's announcement. "The Surfacer system provides us with a safe and effective option for obtaining right-sided central venous access in patients with venous obstructions, enabling us to preserve secondary central veins and avoid alternative access procedures, which are not as effective and have a higher risk of complications."
In February 2020, the company announced that the FDA granted de novo classification clearance for the Surfacer system. The Surfacer system, which received European CE Mark approval in 2016, is distributed in North America and Europe by Merit Medical Systems.