Bluegrass Vascular Technologies Announces Publication of Surfacer System IDE Study Results
San Antonio, TX – July 16, 2020 – 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 the results of its prospective, multicenter SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) study in the Journal of Vascular Access. This U.S. Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) study was designed to evaluate the performance and safety of the Surfacer Inside-Out® Access Catheter System (Surfacer System) when used to facilitate central venous access in patients with thoracic central venous obstructions. The results of this study led to the FDA recently granting De Novo classification of the Surfacer System.
“The SAVE-US study met both its primary safety and effectiveness endpoints while demonstrating the ability to use the Surfacer System to gain central venous access in patients with upper body venous obstructions,” commented Mahmood Razavi, MD, an interventional radiologist at St. Joseph Hospital in Orange, California, the principal investigator for the SAVE-US study and lead author for the publication reporting these results. “The Surfacer System provides a potentially life-saving approach for patients on hemodialysis and other therapies where placement of central venous catheters is required for treatment.”
“The publication of the results of the SAVE-US study further adds to the clinical evidence supporting the valuable role the Surfacer System can have in helping to establish central venous access in patients with venous obstructions,” stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “The findings of this study are consistent with previous reports associated with the use of Surfacer System, confirming the safety and efficacy associated with the use of the device.”
Launch of the Surfacer System in the United States is in progress and first commercial cases were successfully performed in May 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 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 www.bluegrassvascular.com.