First Patients Enrolled in Bluegrass Vascular Post-Market SAVE Study
SAN ANTONIO, TX — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that it has successfully enrolled over one third of its patients in the company’s post-market SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Clinical Study. The SAVE study is an international, prospective, multicenter clinical follow-up study designed to confirm clinical performance and safety of the Surfacer® Inside-Out® Access Catheter System, a novel device indicated for obtaining central venous access to facilitate catheter insertion into the central venous system in patients with chronically occluded veins.
“I look forward to presenting initial results of my experience in the SAVE study at the upcoming Charing Cross Symposium,” stated Vladimir Matoussevitch, MD, Vascular Surgeon at the University Hospital of Cologne in Germany and one of the multicenter Investigators of the SAVE study. “The Surfacer System is an exciting new technology that offers my patients a promising option for reliable catheter placement during AV access creation.”
Early results of the SAVE study will be presented by Vladimir Matoussevitch, MD on Tuesday April 25th from 2:10 – 2:15 p.m. during his presentation “From the Alien to HeRo: first European in-man case of combined use of the Surfacer Inside-Out Device and the HeRo Graft (S)” at the Charing Cross (CX) International Symposium in London, United Kingdom.
“I am extremely pleased by the early positive results and steady enrollment progress of the SAVE study,” stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “Over one third of registry patients have been successfully treated across 6 sites in Europe, bringing us one step closer to preserving access options in patients with compromised central vascular access.”
Bluegrass Vascular will be co-presenting with Merit Medical Systems (Merit Medical), a prominent distributor of medical devices and world-wide distributor of the Surfacer System, during a lunch symposium on Wednesday, April 26th from 12:30-1:30pm titled Surfacer: from Inside-Out Concept to European Use. The symposium will be presented by Gürkan Sengölge, MD, Associate Professor, Interventional Nephrologist at the University of Vienna and John Gurley, MD, Interventional Cardiologist at the University of Kentucky Medical Center and founder of Bluegrass Vascular. The Surfacer System will also be on display at Merit Medical’s exhibitor booth, #415.
The company secured CE Mark approval of the Surfacer System in 2016 and recently announced its strategic, world-wide distribution relationship with Merit Medical, a company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures.
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.
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 bluegrassvascular.com.
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