{"id":17842,"date":"2023-06-16T17:33:27","date_gmt":"2023-06-16T17:33:27","guid":{"rendered":"https:\/\/interhospi.com\/?p=17842"},"modified":"2023-06-16T17:33:27","modified_gmt":"2023-06-16T17:33:27","slug":"breakthrough-bashir-endovascular-catheter-approved-by-fda-for-treatment-of-acute-pulmonary-embolism","status":"publish","type":"post","link":"https:\/\/interhospi.com\/breakthrough-bashir-endovascular-catheter-approved-by-fda-for-treatment-of-acute-pulmonary-embolism\/","title":{"rendered":"Breakthrough BASHIR Endovascular Catheter approved by FDA for treatment of acute pulmonary embolism"},"content":{"rendered":"
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Breakthrough BASHIR Endovascular Catheter approved by FDA for treatment of acute pulmonary embolism<\/h1>\/ in Product News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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The BASHIR Endovascular Catheter, invented at the Lewis Katz School of Medicine at Temple University and developed by Thrombolex, 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 U.S. National Institutes of Health-sponsored multicentre 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.<\/h3>\n

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\u201cThis 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,\u201d 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, which contributed to the invention of platform technology for the device, partnered with Temple on its subsequent development and commercialization.<\/p>\n<\/div><\/section>
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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.<\/p>\n

\u201cThe 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,\u201d said Amy J. Goldberg, MD, FACS, the Marjorie Joy Katz Dean, Lewis Katz School of Medicine. \u201cThe 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.\u201d<\/p>\n

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\u2019s 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.<\/p>\n

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.<\/p>\n

\u201cI am very excited for the FDA approval of the BASHIR Endovascular Catheter for use in acute pulmonary embolism,\u201d 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. \u201cHaving 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.\u201d<\/p>\n

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.<\/p>\n

For more information, visit: https:\/\/thrombolex.com\/products\/bashir-endovascular-catheter\/<\/a><\/p>\n

Digital issue: Please click here<\/a> for more information<\/p>\n<\/div><\/section>
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