FDA Broadens ClearGuard HD Antimicrobial Barrier Cap Indications for CLABSI in Hemodialysis Patients with CVCs

Pursuit Vascular Inc., announced that the US Food and Drug Administration (FDA) granted clearance for a broader indication for ClearGuard HD caps to include reduction in the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with central venous catheters (CVCs).

This expanded clearance was backed by post-market clinical surveillance data. The safety and efficacy of ClearGuard HD caps technology, however, has previously been well established, as they were first cleared for use with hemodialysis catheters in 2013.

“Bloodstream infections can have a devastating effect on patients and contribute significantly to health care costs for insurers and patients,” Doug Killion, president, chief executive officer, Pursuit Vascular, said in a statement. “Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that have a real impact on these patients’ lives.”

The cap is the first and only device cleared to be distributed in the US that kills infection-causing bacteria inside a long-term catheter.

A recent study conducted on the expanded clinical indications demonstrated that use of ClearGuard caps versus Tego Connector plus Curos caps, lowered the bloodstream infection rate in hemodialysis patients using CVCs, representing an advancement in improved patient care. There were no device-related adverse effects reported.

Additionally, a trial representing the largest prospective evaluation of a device for preventing catheter-related bloodstream infections, examined the use of ClearGuard caps versus standard CVC caps. Results showed ClearGuard to significantly lower the rates of catheter-related bloodstream infections and hospital admissions for bloodstream infections in hemodialysis patients using CVCs, providing a clear and significant benefit to patient health in a real-world setting.

The single-use device is protected by 7 issued US patents, and several other US patents pending.