Bluegrass Vascular Technologies Announces First U.S. Commercial Cases with the Surfacer® Inside-Out® Access Catheter System
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, is pleased to announce that the first U.S. commercial cases using the Surfacer® Inside-Out® Access Catheter System were completed at Santa Clara Valley Medical Center in San Jose, California. The procedures were performed by Ehab Sorial, M.D. and Ajit Nair, MD. Dr. Sorial is a Clinical Associate Professor of Surgery in the Division of Vascular Surgery at Stanford University School of Medicine and staff surgeon at Santa Clara Valley Medical Center. Dr. Nair is a staff interventional radiologist at Santa Clara Valley Medical Center. The device was used to obtain venous access in two hemodialysis patients with central venous obstructions, one of which had limited access options. Bluegrass Vascular was granted De Novo classification by the U.S. Food and Drug Administration (FDA) for the Surfacer System in February of this year.
“We are excited to be the first program in the U.S. to incorporate use of the Surfacer System into our day-to-day clinical practice,” said Dr. Nair and Dr. Sorial. “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.”
“Dr. Sorial, Dr. Nair and their team at Santa Clara Valley Medical Center played an integral role as one of several clinical sites for the U.S. investigational device exemption (IDE) study, which led to our recent FDA De Novo clearance. We are honored to have Drs. Sorial and Nair perform our first U.S. cases,” stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “We envision U.S. clinical adoption of the Surfacer System mirroring our positive commercial experiences in Europe and look forward to providing this truly novel technology to physicians and their patients across America.”
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 has received FDA De Novo device clearance in the US and is CE marked in Europe. The device is currently distributed in North America and Europe by Merit Medical, a global manufacturer and 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 bluegrassvascular.com.