SAVE-US Pivotal Trial Receives Positive Clinical Results

SAVE-US trial
Image courtesy of Bluegrass Vascular.


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On June 4th 2019, Bluegrass Vascular Technologies, a private medical company specializing in vascular access devices and procedures, has announced successful enrolment of the SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) trial, which tested the safety and accuracy of SAVE-US.

The Surfacer System achieves successful upper body right-side access to central venous access in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods with their new and improved approach.

“I’m quite encouraged by the highly positive results demonstrated by the Surfacer System,” stated Mahmood Razavi, MD, Interventional Radiologist at St. Joseph Hospital in Orange, California and lead principal investigator of the SAVE-US study. “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.”

There were 30 patients in this trial, of which 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer System. Central venous access was achieved in approximately 12 minutes despite a more complex patient population comprised largely of Type 3 and 4 occlusions.

The U.S. market for vascular access devices and accessories increased in 2017, and growth is expected to persist throughout the forecast period. Market growth will be driven by government policies that encourage safer practices and products, including those introduced by the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). The total value of the U.S. vascular access device market in 2018 was at $4.2 billion, and is expected to continue this trend throughout the forecast period. The market is in good standing for this device’s success; seeing as they are already having positive results, Bluegrass Vascular Technologies is hopeful that this device will receive commercial approval.

“The Surfacer System passed the SAVE-US study with flying colours, confirming the system is a safe, viable option for achieving right-sided central venous access, preserving secondary central veins,” stated Ehab Sorial, MD, Clinical Associate Professor of Surgery in the Division of Vascular Surgery at Stanford in California, staff surgeon at Santa Clara Valley Medical Center in San Jose, CA and the study’s second highest enroller. Dr. Sorial first learned about the Surfacer System while working alongside John Gurley, MD, the system’s inventor, for over a decade at the University of Kentucky. “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.”


For Further Information

More on the vascular access device market in the U.S. can be found in a series of reports published by iData Research, entitled the U.S. Market Report Suite for Vascular Access Devices and Accessories 2018

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