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FDA grants broader indication for ClearGuard HD caps for patients on hemodialysis
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The FDA granted clearance for a broader indication of Pursuit Vascular Inc.’s ClearGuard HD caps to include reduction in the incidence of central-line-associated bloodstream infection in patients on hemodialysis with central venous catheters. The expanded clearance was based on post-market clinical surveillance data.
“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 press release from the company. “Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that have a real impact on these patients’ lives.”
According to the release, the ClearGuard HD cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term catheter. The expanded clinical indications are a result of a study published in the April 2018 issue of the Journal of the American Society of Nephrology. The study, conducted by DaVita Clinical Research, demonstrated use of ClearGuard caps vs. Tego Connector plus Curos caps, lowered the rate of bloodstream infections in patients on hemodialysis who used central venous catheters.
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