October 21, 2018
Bluegrass Vascular Expands SAVE-US IDE Trial and Completes Enrollment in European Postmarket Registry
October 22, 2018—Bluegrass Vascular Technologies, Inc. announced that it has completed enrollment of the prospective, multicenter, international, post–CE Mark approval SAVE registry, which is evaluating the company's Surfacer system to facilitate access in venous occlusions. The Surfacer system received CE Mark approval in 2016. The device is distributed in Europe by Merit Medical Systems, Inc.
Bluegrass Vascular Technologies also announced expanded patient enrollment and study sites in SAVE-US, the premarket investigational device exemption study of the Surfacer system in the United States.
According to the company, positive results in the European study and positive trends in the United States study were demonstrated with use of the Surfacer Inside-Out access catheter system. The device is designed to facilitate upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
The company reported that in the international SAVE registry, central venous catheters were placed according to labeled indications in 29 of 30 patients with 100% success in achieving patency and access. An absence of adverse events were reported for all treated patients, with only a single conversion in one patient (3%) with a significant vascular anomaly preventing access.
All primary safety and performance endpoints were met in 29 of 30 patients. Patients in the study presented with a variety of occlusion types, including 16 patients (30.2%) with bilateral internal jugular and subclavian occlusion, 17 patients (32.1%) with brachiocephalic occlusion, 12 patients (22.6%) with superior vena cava (SVC) occlusion above the azygos, and eight patients (15.1%) with total occlusion of the SVC.
In the company's announcement, SAVE study investigator Maurizio Gallieni, MD, commented, "Completing the postmarket SAVE study reinforces the Surfacer system as the standard of care for central venous obstruction, a serious challenge in the management of hemodialysis patients. It offers a proven and important means of gaining reliable and repeatable central venous access in patients who otherwise have very limited options." Dr. Gallieni is Director of the Nephrology and Dialysis Unit at San Carlo Borromeo Hospital in Milan, Italy.
In the SAVE-US pivotal trial of 30 patients, enrollment was expanded to six sites. The trial will continue to evaluate the safety and efficacy of the Surfacer system as demonstrated in the international SAVE registry.
Eric Peden, MD, vascular surgeon at Houston Methodist Hospital in Houston, Texas, is one of the first enrolling SAVE-US investigators. Dr. Peden commented in the press release, "Central venous occlusion is a major clinical problem for dialysis patients. Early results of the Surfacer system are very encouraging. I look forward to supporting the study to its completion."