Enrollment Completed in the United States Pivotal Trial of Bluegrass Vascular's Surfacer System
June 4, 2019—Bluegrass Vascular Technologies, Inc. announced that it has completed enrollment of the SAVE-US pivotal trial evaluating the safety and efficacy of the company's Surfacer Inside-Out access catheter system in 30 patients at seven centers in the United States.
The Surfacer system is an approach to achieve right-sided, upper body central venous access in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
According to the company, the investigational device exemption (IDE) trial has met its primary and secondary endpoints. Specifically, of the 30 patients enrolled in the SAVE-US trial, 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer system. On average, central venous access was achieved in approximately 12 minutes despite a more complex patient population comprised largely of type III and IV occlusions (three or more occluded vessels).
Mahmood Razavi, MD, Lead Principal Investigator of the SAVE-US study, commented in Bluegrass Vascular's announcement, “I’m quite encouraged by the highly positive results demonstrated by the Surfacer system. I am eager for the system’s commercial approval and look forward to offering a reliable and repeatable solution to patients with varying occlusion types, halting the devastating impact of central venous occlusive disease.”
Ehab Sorial, MD, added, “The Surfacer system passed the SAVE-US study with flying colors, confirming the system is a safe, viable option for achieving right-sided central venous access, preserving secondary central veins. This is a highly anticipated treatment that gives physicians a safe and effective alternative to other less efficacious treatments with higher complication rates. I am looking forward to its commercial approval and implementing it into my day-to-day practice.”
The Surfacer system clinical program includes evidence from 216 cases in subjects with central venous occlusions including results from the IDE SAVE-US trial, international SAVE registry, independent studies, and commercial use surveys. The device has CE Mark approval and is distributed in Europe by Merit Medical Systems, Inc.
The Surfacer system is designed to repeatedly gain central venous access via Bluegrass Vascular's Inside-Out approach, which includes inserting the 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. This 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, stated the company.