New Catheter Leads to Remarkable Reduction in Pulmonary Artery Blockage

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

Evidence of BASHIR performance The catheter comes from data collected from the National Institutes of Health (NIH)-sponsored RESCUE trial, a clinical study designed to assess the safety and effectiveness of the catheter as a new treatment 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.

“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 is also a very safe therapy.” said Riyaz Bashir, MD, FACC, professor of medicine. , Director of Vascular and Endovascular Medicine in the Cardiology Section of the Department of Medicine at Lewis Katz School of Medicine and Temple University Hospital, and co-inventor of the BASHIR Endovascular catheter. Temple has partnered with THROMBOLEX™ Inc., also co-inventor of BASHIR Endovascular Catheter Platform Technology, to drive device development, regulatory pathway and commercialization.

BACHIR The catheter consists 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 surface area of ​​exposure accelerates the breakdown of the clot and the restoration of blood flow through the vessel.

A key clinical feature of the BASHIR™ catheter is its ability to shorten treatment time. “With existing devices, infusion therapy with clot-dissolving drugs can last up to 10 hours,” said Vladimir Lakhter, DO, assistant professor of medicine at the Lewis Katz School of Medicine and interventional cardiologist involved in the trial. RESCUE. “With the BASHIR™ device, the infusion lasts only five hours. Once the device is removed, we are able to see a dramatic decrease in pressure on the heart, providing significant relief to patients.”

As site PI for the RESCUE trial, we pride ourselves on being one of the best recruiting sites. One of the main reasons for this milestone achievement is the multidisciplinary nature of the PERT program and the great benefit this technology can bring to the people we serve at Temple. »


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 investigator in the RESCUE trial

“The RESCUE trial has been an extraordinary journey initiated by dissatisfaction with the historic outcomes of our pulmonary embolism patients, fueled by the power of innovation, validated by excellent clinical trial design and execution, and facilitated through a strong collaborative effort 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 Temple Heart and Vascular Institute.” Indeed, the RESCUE trial marks an important therapeutic milestone for patients with pulmonary embolism.”

“The results of the RESCUE clinical trial are a momentous achievement in the quest to launch new, safe and effective treatments for pulmonary emboli,” said Amy J. Goldberg, MD FACS, acting dean of the 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 by the United States Food and Drug Administration (FDA) in 2019 for the treatment of blood clots in veins and arteries of the peripheral vasculature. THROMBOLEX now has FDA clearance for seven devices in the BASHIR™ family of catheters, all of which are currently in commercialization.

Source:

Journal reference:

Bashir, R. et al. (2022) Prospective Multicenter Trial of Catheter-Directed Pharmacomechanical 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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