The BASHIR™ Endovascular Catheter (THROMBOLEX, Inc.), invented at the Lewis Katz School of Medicine at Temple University and developed by Thrombolex Inc., has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute pulmonary embolism. The approval is based on data from the RESCUE study, a National Institutes of Health-sponsored multicenter clinical trial in which treatment with the BASHIR™ Endovascular Catheter led to rapid and marked improvement in lung artery blockages, resulting in improved heart function in patients with pulmonary embolism.
“This U.S. FDA approval is a significant milestone in acute pulmonary embolism treatment. It marks the availability of a very safe and a highly effective treatment that can be delivered rapidly (within 15 minutes) at most of the hospitals around the globe,” said Riyaz Bashir, MD, FACC, Professor of Medicine at the Katz School of Medicine and Director of Vascular and Endovascular Medicine at Temple University Hospital, and co-inventor of the BASHIR™ Endovascular Catheter. The company THROMBOLEX™ Inc., which contributed to the invention of platform technology for the device, partnered with Temple on its subsequent development and commercialization.
Acute pulmonary embolism, in which blood clots obstruct one or more lung arteries, is the third leading cause of cardiovascular death after heart attack and stroke. Existing treatments have either been suboptimal or highly invasive, and many are associated with a high risk of bleeding and even acute cardiorespiratory failure.
“The approval of the BASHIR™ Endovascular Catheter is great news in the field of pulmonary embolism treatment, and we are proud that this groundbreaking technology was researched and invented at the Lewis Katz School of Medicine at Temple University,” stated Amy J. Goldberg, MD, FACS, the Marjorie Joy Katz Dean, Lewis Katz School of Medicine. “The results of the RESCUE study demonstrate the remarkable potential of the BASHIR™ Endovascular Catheter to change how we treat patients with acute pulmonary embolism and save lives.”
The design of the BASHIR™ catheter helps to overcome many of these challenges. It is a small catheter with a basket of six mini-infusion catheters that can be expanded in a large blood vessel, such as a pulmonary artery. When the helical infusion basket expands within a clot, it opens new channels for blood to flow into the clot, thereby bringing in the body’s own clot-dissolving chemicals. This process also creates more surface area for exposure to clot-dissolving medication administered through the mini-infusion catheters. The system allows for prompt restoration of blood flow and a more thorough clean-up of lung arteries.
In the RESCUE trial, the results of which were published in December 2022 in the Journal of the American College of Cardiology: Cardiovascular Interventions, the BASHIR™ catheter produced more significant reductions in lung artery obstruction than existing therapies for pulmonary embolism. Additionally, it achieved this effect within a substantially shorter duration of treatment. Clot-dissolving drugs must be infused with most existing devices for anywhere from 10 to 20 hours, whereas the BASHIR™ device cuts that time in half, with infusion lasting less than five hours.
“It is an exciting time in treatment of pulmonary embolism with introductions of novel devices like the BASHIR™ Endovascular Catheter,” said Parth Rali, MD, Associate Professor of Thoracic Medicine and Surgery at the Katz School of Medicine, Director of the Temple University Health System Pulmonary Embolism Response Team (PERT), and an investigator on the RESCUE trial. “We were one of the leading sites that recruited patients in the RESCUE trial. The device has shown very good safety and efficacy data.”
“I am very excited for the FDA approval of the BASHIR™ Endovascular Catheter for use in acute pulmonary embolism,” added Vladimir Lakhter, DO, FSVM, Assistant Professor of Medicine, Section of Cardiology, Department of Medicine, at the Katz School of Medicine and Temple University Hospital, and sub-investigator on the RESCUE trial. “Having treated many patients with acute pulmonary embolism using the BASHIR™ catheter, I can attest to its safety and efficacy. Patients feel better quickly and can then be safely discharged from the hospital. I look forward to treating many future patients using this novel and exciting technology.”
“I’m so pleased with the collaborative effort of everyone involved for the benefit of our patients,” said Daniel Edmundowicz, MS, MD, FACP, FACC, Interim Chair of the Department of Medicine and Florence P. Bernheimer Distinguished Service Professorship Chair of Cardiology, Professor and Vice Chair of Program Development in the Department of Medicine at the Katz School of Medicine; Medical Director of the Temple Heart & Vascular Institute; and Director of the Preventive and Integrative Heart Health Program at the Temple Heart & Vascular Institute.
With the new FDA approval, the BASHIR™ catheter is cleared to treat blood clots in the lungs, peripheral veins, and arteries. THROMBOLEX™ now has FDA clearance on seven commercialized devices in the BASHIR™ family of catheters.
Editor’s Note: Dr. Bashir is a co-founder and has an equity interest in Thrombolex, Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Temple University also holds financial interests in the BASHIR™ Endovascular Catheter and other Thrombolex products pursuant to the license granted to Thrombolex for the University’s interest in patents co-invented by Dr. Riyaz Bashir. As a result of these interests, Temple University could ultimately potentially benefit financially from the outcome of this research. These interests have been reviewed and approved by Temple University in accordance with its Institutional Conflict of Interest policy. Questions about this can be directed to [email protected]. Questions regarding individual Lewis Katz School of Medicine researcher interests may be directed to [email protected].