Thrombolex, Inc. has received 510(k) clearance to use the BASHIR™ and BASHIR™ SB Endovascular Catheters for the treatment of acute pulmonary embolism (PE).

New Britain, PA April 20, 2023 –(PR.com)– Thrombolex, Inc. has received 510(k) clearance to use the BASHIR™ and BASHIR™ SB Endovascular Catheters for the treatment of acute pulmonary embolism (PE). This PE-specific clearance was based on positive results from the pivotal RESCUE study funded by the National Heart, Lung and Blood Institute of the National Institutes of Health (Grant # R44HL151032-03) and the Commonwealth of Pennsylvania Department of Health.

Now physicians can offer this novel technology to customize and personalize the care of their patients with PE, the third leading cause of cardiovascular death. The BASHIR™ catheters use a unique combination of mechanical and pharmacological mechanisms of action to safely dissolve blood clots. Targeted thrombolytics are delivered directly into the clot from the expandable infusion basket, allowing for immediate restoration of blood flow and optimal thrombus lysis, helping patients recover quickly.

dr Kenneth Rosenfield, Co-Principal Investigator of the RESCUE Trial and Division Head, Vascular Medicine and Intervention at Massachusetts General Hospital, said, “This represents a significant advance in the treatment of acute pulmonary embolism, with a rapid reduction in right ventricular workload and less than 1 % major bleeding.”

Robert Lookstein, Executive Vice Chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mt. Sinai Hospital, New York, stated, “This novel approach using the BASHIR™ catheter and low-dose tPA demonstrated rapid resolution of the obstruction in the central and segmental pulmonary arteries. The significant reduction in blockages in the segmental arteries is a critical advance in the treatment of this deadly disease.”

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