FDA Clears Thrombolex’s Bashir Endovascular Catheter Short Basket Device

December 16, 2019—Thrombolex, Inc. announced that the company received FDA 510(k) clearance for the Bashir Endovascular Catheter—Short Basket (BEC S-B) for treatment of venous thromboembolic (VTE) conditions. The device’s indication for use is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Thrombolex will introduce the BEC S-B in the United States through a controlled rollout at hospitals with established VTE treatment protocols.

Earlier this year, the Bashir endovascular catheter (BEC) and the Bashir N-X endovascular catheter (BEC N-X) received FDA clearance. The BEC is cleared for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The BEC N-X is intended for the localized infusion of physician-specified fluids, into the peripheral vasculature, including the pulmonary arteries.

According to the company, the Bashir line of interventional catheters rapidly create multiple cross-sectional channels to allow the patient’s own endogenous lytics to immediately begin to flow into the culprit thrombus. The treatment is then enhanced by infusing small amounts of exogenous thrombolytics directly into the culprit thrombus, the combination of which accelerates the dissolution of the clot burden.