BD Receives 510(k) Clearance for Pristine Catheter

BD, a leading global medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Pristine Long-Term Hemodialysis Catheter, a new hemodialysis catheter with a unique side-hole free symmetric Y-Tip distal lumen design.
 
The Pristine Catheter will be available in the U.S. in May 2021.
 
The device was developed by Pristine Access Technologies Ltd., a privately-owned company based in Israel, which was acquired by BD in July 2020 as part of the company’s ongoing growth strategy focused on tuck-in acquisitions and R&D investments in improved treatments for chronic diseases.

Addressing Challenges
Hemodialysis catheters are often challenged by complications. Certain catheter tip designs can lead to complications such as positional occlusion, high recirculation rates, and thrombus formation. These complications can potentially lead to reduced catheter patency and decreased catheter performance. The Pristine Catheter is designed to help address these challenges.
 
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. The symmetric tip is designed to help minimize recirculation rates in both forward and reverse.

Study Results
In a prospective, single-center non-randomized, open-label feasibility study performed outside of the United States, 45 patients who received the 15.5F Pristine Catheter were followed for 6 months post-catheter implantation. All catheters were patent at 30 days post implantation. Primary patency at 60- and 180-days post procedure was 100.0% and 90.9%, respectively.
 
“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,” said Padraic O’Brien, worldwide president of peripheral intervention for BD. “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.”
 
“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,” commented Michael Tal, M.D., founder of Pristine Access Technologies, Ltd. and inventor of the Pristine Catheter. “The Pristine Catheter was designed with hemodialysis patients in mind and to help address some of these concerns.”