FDA approves endovascular catheter for the treatment of acute pulmonary embolism
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Temple University announced that a endovascular catheter, invented at its Lewis Katz School of Medicine and developed by Thrombolex, has been approved by the FDA for treatment of acute pulmonary embolism.
The approval is based on the results from the RESCUE study, published in JACC: Cardiovascular Interventions, for which the endovascular catheter (Bashir) was associated with greater reductions in lung artery obstruction compared with existing therapies for PE and achieved this effect in a shorter duration of treatment, according to a press release.
The small catheter features a basket of six miniature infusion catheters that can be expanded within a clot in a large blood vessel to open new channels for blood to flow into the clot. According to the release, this also creates more surface area for exposure to clot-dissolving medication that can be administered via the six miniature infusion catheters.
“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,” 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 endovascular catheter, said in the release.
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