September 25, 2019
Clinical Results Published for Bluegrass Vascular's Surfacer System
September 24, 2019—Bluegrass Vascular Technologies announced that results associated with the clinical use of the company’s Surfacer Inside-Out access catheter system were published by Dirk M. Hentschel, MD, et al in The Journal of Vascular Access (JVA).
According to the company, the independent, single-center study demonstrated successful use of the Surfacer system in placing hemodialysis catheters for patients with central venous obstruction involving one or more central veins. The mean time for placement and associated fluoroscopy was 13.3 and 3.7 minutes, respectively.
Dr. Hentschel, who is physician proctor for Bluegrass Vascular’s FDA-approved United States investigational device exemption (IDE) clinical study of the device, commented in the company's announcement, “The Surfacer system continues to be a safe and effective solution for accessing obstructed central veins. This is of particular concern and importance for hemodialysis patients who are prone to life-threatening obstructions at vital access points.”
The company stated that the study in JVA adds to the evidence demonstrating that the Surfacer system is a safe and reliable option for achieving right-sided central venous access and a viable means to preserving secondary central veins. Additional evidence resulting from successful use of the Surfacer system in hemodialysis patients awaiting the creation and/or maturation of an arteriovenous fistula was recently published by Lawrence Han Hwee Quek, MD, et al online ahead of print in Hemodialysis International.
Additionally, positive results from the company’s IDE study and European postmarket SAVE registry will be presented by Mahmood Razavi, MD, during the Controversies in Dialysis Access meeting being held October 30–November 1 in San Diego, California. Gürkan Sengölge, MD, will also be presenting data from the SAVE registry during the American Society of Nephrology 2019 annual meeting held November 7–10 in Washington, DC.
The company recently filed a de novo request for the Surfacer system with the FDA based on the positive clinical results of the company’s SAVE-US pivotal trial.
Bluegrass Vascular anticipates that the FDA will grant the request and the Surfacer system will be commercially available in the United States in 2020. In Europe, the Surfacer system has CE Mark approval and is distributed by Merit Medical.