The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous catheters. The company noted that bloodstream infection is the leading cause of hospitalizations and the second-leading cause of death in hemodialysis patients; catheters cause such infections more than two-thirds of the time.
“Bloodstream infections can have a devastating effect on patients and contribute significantly to health care costs for insurers and patients,” Doug Killion, president and CEO of Pursuit Vascular, said in a news release. “Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that have a real impact on these patients’ lives.”
Pursuit Vascular boasts that the ClearGuard HD cap is the first and only device cleared for sale in the U.S. to kill infection-causing bacteria inside a long-term catheter.
DaVita Clinical Research conducted a study, published in the April 2018 Journal of the American Society of Nephrology, that demonstrated that use of ClearGuard caps versus Tego Connector plus Curos caps, lowered the rate of bloodstream infections in hemodialysis patients using central venous catheters, according to Pursuit Vascular. The DaVita study built on previous research and provided needed backing to win the broader indication from FDA.