Thrombolex Begins Early Feasibility and Safety Study of the Bashir Catheter for PE

July 29, 2019—Thrombolex, Inc. announced the enrollment of the first patient in the early feasibility and safety study investigating the company's Bashir endovascular catheter for the treatment of submassive pulmonary embolism (PE).

According to the company, the Thrombolex investigational trial is designed to examine if lower doses of thrombolytic via the Bashir endovascular catheter can be administered much more effectively over less time and thereby minimize major bleeding complications. The 10-patient prospective, multicenter clinical study will evaluate the feasibility and safety of the Bashir endovascular catheter to treat patients with intermediate-risk PE.

The purpose of this investigational study is to seek additional clearance for the treatment of PE. The Bashir endovascular catheter, which is specifically designed to be used in the treatment of large clots in the vasculature, currently has FDA 510(k) clearance for localized infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The device is currently contraindicated in the pulmonary and coronary arteries and neurovasculature.

Thrombolex stated that the Bashir endovascular catheter quickly and safely dissolves thrombus and restore blood flow in patients with thrombotic vascular occlusions. The device includes an expandable infusion basket composed of six mini-infusion catheters with 48 precision, laser-drilled infusion holes. When expanded, it can promptly restore blood flow to enable endogenous lytics in the blood to help accelerate clot lysis. In this investigational study, the device is used to administer thrombolytics through multiple cross-sections of the culprit clot to enhance clot dissolution.

Parth Rali, MD, Assistant Professor, Thoracic Medicine, and Surgery at Lewis Katz School of Medicine at Temple University in Philadelphia, Pennsylvania, commented in the company announcement, "We are pleased to have been the first site to enroll a patient in the Thrombolex early feasibility and safety study. The Bashir endovascular catheter removed a large volume of clot from the pulmonary arteries efficiently, and safely restored blood flow, that resulted in a very rapid improvement in the patient's overall clinical status.”

In this patient with a critical, large submassive PE that severely compromised blood flow to both lungs, a total of 14 mg of recombinant tissue plasminogen activator (r-tPA) was administered over 8 hours. Riyaz Bashir, MD, stated "There was a dramatic improvement in the patient's hemodynamic state and oxygenation as well as evidence of a marked reduction in clot burden as compared to what has been seen in other catheter-directed thrombolysis studies using a similar dose of r-tPA," Dr. Bashir is Director of Vascular and Endovascular Medicine at Temple University Hospital.