SAN ANTONIO, Sept. 24, 2019 /PRNewswire/ -- Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of positive results associated with the clinical use of the Surfacer® Inside-Out® Access Catheter System in the peer-reviewed Journal of Vascular Access (JVA).
Results of an independent, single-center study demonstrated successful use of the Surfacer System in placement of 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 min, respectively.
"The Surfacer System continues to be a safe and effective solution for accessing obstructed central veins," states Dirk Hentschel, M.D., co-author of the publication and physician proctor for the company's FDA approved U.S. Investigational Device Exemption (IDE) clinical study. "This is of particular concern and importance for hemodialysis patients who are prone to life-threatening obstructions at vital access points."
The newly published study in JVA adds to the growing body of evidence demonstrating 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 the successful use of the Surfacer System hemodialysis patients awaiting the creation and/or maturation of an arteriovenous (AV) fistula was also recently reported in Hemodialysis International.
Positive results from the company's IDE study and European post-market SAVE Registry will be presented by Mahmood Razavi, M.D., Director of Clinical Trials at St. Joseph's Vascular Institute in Irvine, California during the upcoming Controversies in Dialysis Access (CiDA) meeting being held from October 30th to November 1st in San Diego, CA. Gürkan Sengölge, M.D., Associate Professor of Medicine, Nephrology and Intensive Care Medicine at the Medical University of Vienna, will also be presenting data from the SAVE Registry during the upcoming American Society of Nephrology (ASN) 2019 Annual Meeting being held November 7th to 10th in Washington, D.C.
"The Surfacer System clinical program includes evidence from 3 clinical studies with over 60 patients treated, demonstrating significant clinical impact across a broad spectrum of occlusion types," states Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. "We are pleased with this ongoing momentum and look forward to bringing this valuable technology to physicians and their patients in the U.S."
The company recently filed a de novo request for the Surfacer System with the U.S. Food and Drug Administration (FDA) based on the positive clinical results of the company's SAVE-US pivotal trial. The company anticipates that FDA will grant the request and the Surfacer System will be commercially available in the U.S. in 2020.
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 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 prominent 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. For more information, please visit www.bluegrassvascular.com.
SOURCE Bluegrass Vascular Technologies