Pursuit Vascular, Inc. today announced publication of a study in the Journal of American Society of Nephrology (JASN) featuring the company’s ClearGuard HD Antimicrobial Barrier Cap for use in hemodialysis catheters. The study, conducted by DaVita Clinical Research, was the second major prospective randomized controlled trial (RCT) of the ClearGuard HD antimicrobial cap, and the first major prospective RCT comparing two different devices specifically designed to mitigate the risk of bloodstream infections (BSIs) in hemodialysis patients.
This 13-month, prospective, multicenter, cluster-randomized trial included 1671 patients accruing approximately 183,000 treatment-days at 40 dialysis centers across the United States. Participating centers were randomized to either treat patients using the ClearGuard HD Antimicrobial Barrier Cap (intervention group) or Tego Connector in combination with Curos cap (control group).
The primary outcome of the study was the number of positive blood cultures as an indicator of BSI rate. This study demonstrated that use of ClearGuard HD caps resulted in a 63% lower BSI rate vs. use of Tego+Curos. Additional exploratory analyses were performed which demonstrated that ClearGuard HD caps are superior to Tego+Curos for reducing BSI by 63-82% across all nine analyses. These study findings are consistent with an earlier independent study by Fresenius Kidney Care which used a different control group.
BSI is the leading cause of hospitalizations and the second leading cause of death in hemodialysis patients, with catheters causing 70% of BSIs. Data from the National Healthcare Safety Network (NHSN) reported 30,000 BSIs in outpatient hemodialysis centers in 2014. The ClearGuard HD cap is the first and only device cleared for sale in the U.S. that kills infection-causing bacteria inside a long-term catheter.
“These findings represent an important advancement in hemodialysis care for patients who are receiving dialysis,” said Doug Killion, President and CEO of Pursuit Vascular. “The ClearGuard HD cap is a first-of-its kind device, and these results demonstrate that it provides a clear and significant benefit to patient health.”
The ClearGuard HD Antimicrobial Barrier Cap is the first and only device cleared for sale in the U.S. that kills infection-causing bacteria inside a long-term hemodialysis catheter. The caps are simple to use and clinically shown to reduce central line-associated bloodstream infection. This simple, yet revolutionary single-use device is protected by 7 issued U.S. patents, and several other U.S. patents pending. Foreign patents issued and pending.