Health

New catheter leads to a remarkable reduction in pulmonary artery obstruction

A device known as the BASHIR Endovascular catheter (THROMBOLEX, Inc.) significantly reduces the size of blood clots trapped in the pulmonary arteries, leading to an improvement in heart function in patients with pulmonary embolism, researchers from the Lewis Katz School of Medicine at Temple University announced in a Late -Breaking Innovation Session at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference in Boston. The breakthrough is detailed in a report simultaneously published online in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Evidence for the execution of the BASHIR catheter comes from data collected in the National Institutes of Health (NIH) sponsored RESCUE trial, a clinical trial designed to evaluate the safety and efficacy of the catheter as a novel therapy for pulmonary embolism. The magnitude of the reduction in the size of the clots obstructing the pulmonary artery in the RESCUE trial was significantly greater than the reductions reported for therapies currently used in the treatment of pulmonary embolism.

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“For the first time, we can demonstrate that this treatment not only leads to a remarkable reduction in pulmonary artery obstruction in patients with pulmonary embolism, but is also a very safe therapy,” said Riyaz Bashir, MD, FACC, Professor of Medicine, Director of Vascular and Endovascular Medicine in the Department of Cardiology Department of Medicine, at the Lewis Katz School of Medicine and Temple University Hospital, and co-inventor of the BASHIR Endovascular catheter. Temple partnered with the company THROMBOLEX™ Inc., also a co-inventor of the BASHIR Endovascular catheter platform technology, to advance the development, regulatory journey and commercialization of the device.

the BASHIR catheter is made of an expandable basket with mini infusion catheters. Once placed in a clot, the IV basket expands, creating new channels in the clot and thereby increasing the surface area exposed to clot-dissolving drugs delivered through the catheters. The larger area of ​​exposure accelerates the breakdown of clots and the restoration of blood flow through the vessel.

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An important clinical feature of the BASHIR™ catheter is its ability to reduce treatment time. “With existing devices, treatment by infusion of clot-dissolving drugs can take as long as 10 hours,” explains Vladimir Lakhter, DO, assistant professor of medicine at the Lewis Katz School of Medicine and an interventional cardiologist involved in the RESCUE study. “With the BASHIR™ device, the infusion takes just five hours. Once the device is removed, we can see a dramatic reduction in the load on the heart, providing significant relief for patients.”

As a site PI for the RESCUE trial, we pride ourselves on being one of the best recruiting sites. A major reason for this milestone is the multidisciplinary nature of the PERT program and the significant benefit this technology can bring to the populations we serve at Temple.”

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Parth Rali, MD, associate professor of thoracic medicine and surgery, Lewis Katz School of Medicine, director, Temple University Health System Pulmonary Embolism Response Team (PERT), and an investigator of the RESCUE study

“The RESCUE study was an extraordinary journey started by dissatisfaction with historical outcomes for our patients with pulmonary embolism, fueled by the power of innovation, validated by excellent clinical trial design and conduct, and enabled by a strong collaboration here at Temple and with our collaborators across the country,” said Daniel Edmundowicz, MD, MS, FACC, professor of medicine and chief of cardiology at the Lewis Katz School of Medicine and medical director of the Temple Heart and Vascular Institute. “Indeed, the RESCUE study marks an important therapeutic milestone for patients with pulmonary embolism.”

“The results of the RESCUE clinical trial are an important achievement in the search for new treatments for pulmonary embolism that are safe and effective,” said Amy J. Goldberg, MD FACS, Interim Dean, Lewis Katz School of Medicine. “It is also a testament to the scientific and clinical research of Dr. Bashir, Dr. Lakhter and Dr. Rali, their teams and Temple. I am so proud to have these outstanding leaders as part of our Temple Health family”

The BASHIR™ catheter was approved in 2019 by the US Food and Drug Administration (FDA) for the treatment of blood clots in veins and arteries in the peripheral vascular system. THROMBOLEX now has FDA approval for seven devices in the BASHIR™ family of catheters, all of which are currently on the market.

Source:

Temple University Health System

Reference magazine:

Bashir, R., et al. (2022) Prospective multicenter study of pharmacomechanical catheter-directed thrombolysis with the Bashir endovascular catheter for acute pulmonary embolism. Journal of the American College of Cardiology: Cardiovascular Interventions. doi.org/10.1016/j.jcin.2022.09.011.

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