BD (NYSE:BDX) this week said it has received FDA 510(k) clearance for its Pristine long-term hemodialysis catheter.
The catheter has a side-hole free symmetric Y-tip distal lumen design that is designed to minimize thrombus adhesion and help facilitate blood clot aspiration prior to hemodialysis treatment. Its symmetric tip is designed to help minimize recirculation rates in forward and reverse.
“The clearance of the BD Pristine catheter adds to our diversified portfolio of products in support of clinicians who care for patients with end stage kidney disease (ESKD) who require hemodialysis,” Padraic O’Brien, worldwide president of peripheral intervention, said in a news release. “This exciting technology is highly complementary to our current ESKD portfolio and will enable us to offer a differentiated product that can help to improve the patient experience.”
Pristine was developed by Pristine Access Technologies, an Israel-based company that was acquired by BD in July 2020.
In a prospective, single-center non-randomized, open-label feasibility study performed outside of the U.S. 45 patients who received BD’s 15.5F Pristine catheter had patent catheters at 30 days post-implantation. Primary patency at 60- and 180-days post procedure was 100% and 90.9% respectively.
“A majority of hemodialysis patients in the United States start their treatment with a catheter and many of those catheter-dependent patients will suffer a catheter-related complication at some point during treatment, which can adversely impact the patient and create additional healthcare system costs,” Michael Tal, founder of Pristine Access Technologies and inventor of the catheter, said. “The Pristine Catheter was designed with hemodialysis patients in mind and to help address some of these concerns.”
