April 15, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced it 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. (Isreal), a privately-owned company that 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.
BD says that the Pristine Catheter is designed to help address common challenges faced by other hemodialysis catheters, such as positional occlusion, high recirculation rates, and thrombus formation, which can potentially lead to reduced catheter patency and decreased catheter performance.
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.