April 2, 2019
Pursuit Vascular's ClearGuard HD Caps Receive CE Mark Approval
April 3, 2019—Pursuit Vascular, Inc. announced that the company's ClearGuard HD antimicrobial barrier caps have received both European CE Mark approval and the Medical Device Single Audit Program (MDSAP) certificate. The milestones pave the way for launch of the device in international markets.
According to the company, the ClearGuard HD caps are designed to kill infection-causing microorganisms inside a catheter hub between dialysis treatments. The company noted that catheters cause the majority of bloodstream infections, the second leading cause of death and a leading cause for hospitalization in hemodialysis patients.
CE Mark approval allows the company to commercialize ClearGuard HD caps in the European Union and other CE Mark geographies. The MDSAP certificate demonstrates compliance with regulations in Canada, Australia, and Brazil. The company is pursuing applications to market in these countries to facilitate the launch of ClearGuard HD caps internationally later this year.
Pursuit Vascular's ClearGuard HD caps are available in the United States. Published landmark clinical studies demonstrate an approximately 70% reduction in bloodstream infections in patients using ClearGuard HD caps versus patients using standard caps or needleless connectors, stated the company.