Pursuit Vascular, Inc., manufacturer of ClearGuard HD Antimicrobial Barrier Caps, has announced that the company has received both (CE) Mark and Medical Device Single Audit Program (MDSAP) certificates for its haemodialysis catheter caps, paving the way for launch in international markets.
The CE marking confirms that the device meets the requirements of the European Medical Devices Directive, which now allows Pursuit Vascular to commercialise their catheter 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 launch of ClearGuard HD caps internationally later this year.
“The CE Mark and MDSAP approvals are significant accomplishments for Pursuit Vascular as it allows the company to expand sales to Europe and other key international markets,” said Doug Killion, president and CEO. “We look forward to working with hospitals and physicians in these countries to bring this lifesaving technology to more patients worldwide.”
The company has seen rapid uptake of the catheter caps in the USA following publication of landmark clinical studies demonstrating a ~70% reduction in bloodstream infections in patients using ClearGuard HD caps versus patients using standard caps or needleless connectors. The cap is the first and only device available for sale that kills infection-causing microorganisms inside a catheter hub between dialysis treatments. Bloodstream infection is the second leading cause of death and a leading cause for hospitalisation in haemodialysis patients, with catheters causing the majority of these infections.
“The extraordinary success of ClearGuard HD caps in the USA clearly demonstrates that we have been able to provide a highly effective product that is rapidly becoming the standard of care for dialysis treatment,” continued Killion. “Pursuit Vascular is committed to creating technologies that aid in the prevention of catheter-related infection to enhance and extend the lives of patients around the world, and to reduce healthcare costs.”