BD’s Aspirex System Cleared for Hemodialysis Access of AVGs and AVFs

April 28, 2023—BD (Becton, Dickinson and Company) announced that the Aspirex mechanical aspiration thrombectomy system—specifically, with 6- and 8-F catheters—has received FDA 510(k) clearance for an additional indication of the removal of acute emboli and thrombi for hemodialysis access of arteriovenous grafts (AVGs) and native arteriovenous fistulas (AVFs).

BD launched the Aspirex system in 2022 after receiving the initial FDA 510(k) clearance for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

According to the company, the Aspirex system utilizes a three-in-one mechanism of action. In a single session, the device provides advanced clot aspiration, continuous clot maceration to help mitigate clogging, and mechanical transportation to help facilitate efficient clot removal through the catheter and out of the vessel.

JD Meler, MD, who is Vice President of Medical and Clinical Affairs for Peripheral Interventional at BD, commented in the company’s press release, “The majority of patients with end-stage kidney disease use an AVF or AVG as their lifeline for hemodialysis. The Aspirex thrombectomy system is designed to help restore the patency of a thrombosed AVG or AVF, allowing for life-saving hemodialysis treatment.”