BD’s Pristine Long-Term Hemodialysis Catheter Cleared by FDA

April 14, 2021—BD (Becton, Dickinson and Company) announced it has received 510(k) clearance from the FDA for the Pristine long-term hemodialysis catheter. The device features a side-hole–free symmetric Y-Tip distal lumen design. The Pristine catheter will be available in the United States in May 2021.

According to BD, the Pristine catheter’s side-hole–free tip is designed to help minimize thrombus adhesion that can be associated with side-hole catheters and to help facilitate blood clot aspiration prior to hemodialysis treatment. Additionally, the symmetric tip is designed to help minimize recirculation rates in both forward and reverse.

The company noted that the Pristine device was evaluated in a prospective, single-center nonrandomized, open-label feasibility study performed outside of the United States. In the study, 45 patients who received the 15.5-F Pristine catheter were followed for 6 months postcatheter implantation. All catheters were patent at 30 days after implantation. Primary patency was 100% at 60-days and 90.9% at 180-days postprocedure.

The catheter was developed by Pristine Access Technologies, Ltd., a privately owned company based in Israel, which was acquired by BD in July 2020. Michael Tal, MD, Founder of Pristine Access Technologies, is the inventor of the Pristine catheter.

Dr. Tal commented in BD’s press release, “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. The Pristine catheter was designed with hemodialysis patients in mind and to help address some of these concerns.”