New Britain, PA – (June 25, 2025) – Thrombolex, Inc., a medical device manufacturer committed to advancing solutions for the treatment of arterial and venous thromboembolic diseases, announced the publication of the results from the RESCUE-II Study in JACC: Advances. The RESCUE-II Study was a single-center, prospective study evaluating the safety and feasibility of OTT pharmaco-mechanical lysis (PML) without postprocedural infusion when treating patients with acute intermediate-risk PE. 9 patients were enrolled and successfully treated with low dose r-tPA (4mg per pulmonary artery) using the BEC. At 48 hours, the mean RV/LV ratio decreased by 22.3%, and pulmonary artery obstruction, as measured by the Refined Modified Miller Index, was reduced by 29.2%. There were no major bleeding events, no deaths or serious adverse events through 30-day follow-up.
“This marks a significant milestone for our Company, as we are proud to contribute high quality evidence to the field and remain committed to advancing innovative treatments.” said Michael Cerminaro, President & CEO of Thrombolex. “We would like to thank Senator Steve Santarsiero and the Department of Community and Economic Development of the Commonwealth of PA for their grant funding support of this important clinical research.”
“The RESCUE-II Study demonstrated encouraging safety and feasibility, while reinforcing the clinical value of this novel OTT protocol”, said, Dr. Vlad Lakhter, IC at Temple University Hospital. “These results warrant further investigation in larger, multicenter trials like the RAPID-PE Study, which is currently enrolling patients.”
An independent data safety monitoring board adjudicated all clinical events for the RESCUE-II Study, while imaging data was assessed by an independent Core laboratory.
The publication is available online in JACC: Advances:
About Thrombolex, Inc.
Founded in 2016, Thrombolex is engaged in the design, development, and distribution of innovative endovascular catheters used in interventional procedures, particularly in pharmaco-mechanical lysis (PML) in patients who suffer from arterial and venous thromboembolic conditions. The Company is currently marketing eight (8) different FDA-cleared devices that are all based on the BASHIR™ Endovascular Catheter platform technology. For general inquiries, please contact Thrombolex at info@thrombolex.com or for more information about Thrombolex and its solutions, visit www.thrombolex.com.
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