Results Presented for Bluegrass Vascular's Surfacer Access Catheter System
October 27, 2018—Bluegrass Vascular Technologies announced the presentation of results for its Surfacer Inside-Out access catheter system in a poster session at the 2018 American Society of Nephrology annual meeting held October 23–28 in San Diego, California.
The Surfacer system is a CE Mark-approved device designed to reliably, safely, and repeatedly gain central venous access for hemodialysis patients awaiting maturation of permanent vascular access. The Surfacer is distributed in Europe by Merit Medical.
According to the company, the data demonstrated positive commercial use with the device, which consistently achieved central venous access in patients with upper body occlusions. The study builds on positive results from the company's postmarket international SAVE Registry announced earlier this month.
The results of the retrospective independent study evaluating 32 patients treated with the Surfacer system demonstrated a 97% success rate. Access was not achieved in one patient because of significant scoliosis altering the anatomy. There were no reported device-related complications (including bleeding, hematoma, and catheter-related infection), and all patients displayed similar catheter function at 3 months.
In Bluegrass Vascular's press release, study investigator Roman Reindel-Schwaighofer, MD, commented, "The clinical application of the Surfacer system, as shown in this study, proves to be extremely positive. The Surfacer system provides a safe and effective solution that both preserves and restores vascular access for patients requiring hemodialysis who otherwise have very limited options." Dr. Reindel-Schwaighofer is a Nephrology and Dialysis Fellow at the Medical University of Vienna in Vienna, Austria.
The study's lead investigator, Gürkan Sengölge, MD, added, "Based on these results, I am very optimistic about the clinical impact of the Surfacer system and its ability to treat upper body vascular occlusions. The ability to safely perform the procedure, in an outpatient setting, and have the option to repeat when necessary has the potential to change the standard of care going forward." Dr. Sengölge is Associate Professor of Medicine, Nephrology, and Intensive Care Medicine at the Medical University of Vienna.