Thrombolex Bashir Catheter Cleared by FDA to Treat Acute Pulmonary Embolism

April 20, 2023—Thrombolex, Inc. announced FDA 510(k) clearance for use of the company’s Bashir and Bashir S-B endovascular catheters for the pharmacomechanical catheter-directed thrombolysis (PMCDT) treatment of acute pulmonary embolism (PE). The cleared Bashir catheters are available for immediate shipment to hospitals in the United States. Thrombolex is scheduling installation and in-service training.

According to the company, the Bashir devices use PMCDT—a combination of mechanical and pharmacologic mechanisms of action—to safely resolve blood clots. Targeted thrombolytics are delivered from the device’s expandable infusion basket directly into the clot, thereby enabling the immediate restoration of blood flow and optimal resolution of thrombus, helping patients to recover rapidly.

Thrombolex advised that this clearance specifically for PE was based on the positive results from the pivotal RESCUE study, which was funded by the National Heart, Lung and Blood Institute of the National Institutes of Health and the Commonwealth of Pennsylvania’s Department of Health. Thrombolex is headquartered in New Britain, Pennsylvania.

Kenneth Rosenfield, MD, who is Coprincipal Investigator of the RESCUE trial commented in the company’s press release, “This represents a significant advance in the treatment of acute PE, with a rapid reduction in right ventricular strain and less than 1% rate of major bleeding.” Dr. Rosenfield is Section Head, Vascular Medicine and Intervention at the Massachusetts General Hospital in Boston, Massachusetts.

Robert Lookstein, MD, added, “This novel approach with the Bashir catheter and low dose tissue plasminogen activator demonstrated rapid resolution of obstruction in the central and the segmental pulmonary arteries. The striking reduction of blockages in the segmental arteries is a crucial step forward in the treatment of this deadly disease.” Dr. Lookstein is Executive Vice Chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital in New York, New York.

In March, the company announced that Dr. Lookstein presented data from a subanalysis of the RESCUE trial at SIR 2023, the Society for Interventional Radiology’s annual scientific meeting held March 4-9, 2023, in Phoenix, Arizona.

The final results from the RESCUE trial were presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.