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June 30, 2021
Thrombolex Bashir Catheters Receive Enhanced Indication for Use From FDA
June 30, 2021—Thrombolex, Inc. announced it has received approval from the FDA for enhanced Indication for Use for the Bashir endovascular catheter and the Bashir Plus endovascular catheters (Bashir +10, Bashir +20, Bashir +30, and Bashir +40). These devices are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
According to the company, the specific indication reinforces the purpose of catheters as devices that not only clear thrombus but also restore blood flow through the vessel.
To continue expanding the devices’ Indication for Use, Thrombolex is currently enrolling patients in its pivotal RESCUE trial for the treatment of patients with acute submassive pulmonary embolism (PE). This trial is using the Bashir endovascular catheter under an investigational device exemption from the FDA. The goal of the RESCUE trial is to achieve an additional indication for use of the device in the treatment of PE. The company announced commencement of the trial in August 2020.
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