Thrombolex Bashir Catheter Analyzed for Acute Intermediate-Risk PE Patients in RESCUE

October 24, 2023—Thrombolex, Inc., a Pennsylvania-based medical device company focused on the treatment of arterial and venous thromboembolic diseases, announced the publication of an independent core-lab data analysis of 107 patients with acute intermediate-risk pulmonary embolism (PE) treated with the company’s Bashir endovascular catheter and small doses of recombinant tissue plasminogen activator (r-tPA) at 18 sites in the United States.

The company stated that the data from the National Institutes of Health-sponsored RESCUE trial showed major reductions in obstruction in all of the segmental pulmonary arteries (PAs) as well as efficacy and safety in this patient population compared to recently published studies with other FDA-cleared devices.

The findings were published by Riyaz Bashir, MD, et al online in JACC: Advances.

According to Thrombolex, the RESCUE trial demonstrated that pharmacomechanical catheter-directed thrombolysis therapy using the Bashir endovascular catheter to administer r-tPA in small doses (7 mg for unilateral and 14 mg for bilateral PE over 5 hours) resulted in a 71.1% reduction (40.5% to 11.7%; P < .0001) in the number of segmental PA branches with total or subtotal occlusions at 48 hours, using contrast-enhanced chest CT angiography.

Additionally, proximal PA branch total or subtotal occlusions decreased by 61.3% (28.7% to 11.0%; P < .0001). The reduction in segmental artery occlusions correlated significantly with the reduction in right ventricular/left ventricular ratio (P = .0026) whereas that in the proximal PA did not (P = .173).

Gregory Piazza, MD, Associate Professor of Medicine at Harvard Medical School in Boston, Massachusetts, serves as Chairman of the RESCUE data safety monitoring board.

“A growing body of literature supports the hypothesis that reperfusion of the distal pulmonary vasculature is a critical therapeutic target, influencing right ventricular recovery, symptom relief, and gas exchange,” commented Dr. Piazza in the company’s press release.

Brian G. Firth, MD, Chief Scientific Officer of Thrombolex, added, “The critical finding in the present study is that by using the Bashir endovascular catheter and small doses of tPA we are able to markedly reduce segmental and main pulmonary arterial occlusions. Assessment of segmental artery patency after catheter-based therapies of acute PE may be critical to understanding the long-term benefits of these therapies and should be part of all future clinical trials in acute PE.”

Thrombolex advised it is currently marketing eight different FDA-cleared devices that are based on the Bashir endovascular catheter platform technology.