A breakthrough device significantly reduces the size of blood clots lodged in the pulmonary arteries, leading to improvement in heart function in patients with pulmonary embolism, according to findings of a clinical study.

The new device known as the BASHIR Endovascular Catheter was developed by researchers at the Lewis Katz School of Medicine at Temple University (Philadelphia, PA, USA) in association with THROMBOLEX, Inc. (New Britain, PA, USA). The BASHIR catheter is made of an expandable basket with mini-infusion catheters. Once placed inside a clot, the infusion basket expands, creating new channels in the clot and thereby increasing the surface area exposed to clot-dissolving drugs delivered through the catheters. The greater exposure area accelerates clot breakdown and the restoration of blood flow through the vessel. A key clinical feature of the BASHIR catheter is its ability to shorten treatment duration.

Evidence for the performance of the BASHIR catheter comes from data collected in the RESCUE trial, a clinical study designed to evaluate the safety and efficacy of the catheter as a novel therapy for pulmonary embolism. The magnitude of reduction in the size of clots obstructing the pulmonary artery in the RESCUE trial was significantly greater than reductions reported for therapies currently used in the treatment of pulmonary embolism. The BASHIR catheter was approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of blood clots in veins and arteries in the peripheral vasculature. THROMBOLEX now has FDA clearance on seven devices in the BASHIR family of catheters, all of which are currently in commercialization.

“For the first time, we are able to show that this treatment not only leads to a remarkable reduction in pulmonary artery obstruction in patients with pulmonary embolism but also is a very safe therapy,” said Riyaz Bashir, MD, FACC, Professor of Medicine, Director of Vascular and Endovascular Medicine in the Section of Cardiology Department of Medicine, at the Lewis Katz school of Medicine and Temple University Hospital, and co-inventor of the BASHIR Endovascular Catheter.

“With existing devices, treatment by infusion of clot-dissolving drugs can last as long as 10 hours,” explained Vladimir Lakhter, DO, Assistant Professor of Medicine at the Lewis Katz School of Medicine and an interventional cardiologist involved in the RESCUE trial. “With the BASHIR device, infusion lasts only five hours. Once the device is removed, we are able to see a dramatic decrease in strain on the heart, bringing significant relief for patients.” 

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