Thrombolex Bashir® Endovascular Catheter First-In-Human (FIH) Trial for Acute Pulmonary Embolism Confirms Early Safety and Feasibility and Impressive Reduction of Clot Burden
Results of FIH Trial presented at American Venous Forum (AVF) Annual Meeting
AMELIA ISLAND—Thrombolex, Inc., a medical device company focused on the design, development and manufacture of innovative endovascular therapies for the treatment of arterial and venous thromboembolic disorders, today announced that its First-In-Human (FIH) trial confirms the early safety and feasibility of using the Bashir® Endovascular Catheter for pharmaco-mechanical catheter-directed thrombolysis (CDT) in patients with acute pulmonary embolism (PE). The data were presented today at the American Venous Forum (AFV) Annual Meeting in Amelia Island, FL and showed a significant reduction in right ventricular to left ventricular (RV/LV) diameter ratio and clot burden.
"The results from the First-in-Human study for the Bashir Endovascular Catheter are exciting -- the PE patients treated were real-world patients that had high thrombus burden and major right ventricular dilation. The amount of thrombus removed with less than 14 mg of tissue plasminogen activator (r-tPA) was impressive. I look forward to seeing what this device can do in a larger study and a randomized cohort", said Akhilesh Sista, MD, FSIR, FAHA, Thrombolex FIH study Co-Principal Investigator, chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine, and vice chair of the recently published Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association.
The Thrombolex FIH trial was a prospective, single-arm, multicenter study conducted under an Investigational New Drug (IND) assignment from the U.S. Food and Drug Administration (FDA) that evaluated the safety and feasibility of the Bashir® Endovascular Catheter in the treatment of patients with acute pulmonary embolism (ClinicalTrials.gov Identifier NCT03927508). The study enrolled 9 participants across 4 U.S. study centers.
The Thrombolex FIH study demonstrated excellent safety, as there were no drug or devicerelated adverse events, as adjudicated by the Data Safety Monitor. The primary feasibility endpoints were met with a significant mean reduction in right ventricular to left ventricular (RV/LV) diameter ratio. The RV/LV ratio decreased from 1.52 ± 0.26 pre-procedure to 0.97 ± 0.06 (p=0.0009), corresponding to a 36.7 % reduction, at 48 hours after intervention. Likewise, the Modified Miller Index (MMI) demonstrated a decreased from 25.4 ± 5.3 pre-procedure to 16.0 ± 4.0 at 48 hours (p=0.0005), corresponding to a 37.1% reduction, after a mean dose of 13.6 mg of r-tPA over 8 hours. “The innovative design of the Bashir Endovascular Catheter enables it to engage and fissure the thrombus, as well as deliver fibrinolytic throughout the entire crosssectional volume of the clot. In theory, this potentially allows for more prompt restoration of flow to the lungs and relief of right ventricular overload. The results of this EFS study appear to corroborate this mechanism of action. We look forward to further evidence of this effect in a larger cohort”, said Kenneth Rosenfield, MD, FACC, MSCAI, Thrombolex FIH Co-Principal Investigator, co-founder of the PERT Consortium, Interventional Cardiologist and Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital.
Both the reduction in RV/LV ratio and the reduction in clot burden as measured by the MMI score compare very favorably with what has been published in ultrasound assisted catheter-directed thrombolysis and mechanical thrombectomy device trials. This study will be followed by a much larger pivotal trial in patients with acute pulmonary embolism. “We are excited about the excellent results of our FIH trial, which has demonstrated prompt restoration of blood flow with rapid clot dissolution and reduced RV strain. We look forward to collaborating with physicians who work in this field to bring better treatment options to patients”, commented Marv Woodall, Chairman & CEO.
About Thrombolex, Inc.
Founded in 2016, Thrombolex, Inc. is engaged in the design, development, manufacture and distribution of innovative endovascular catheters used in interventional procedures, particularly in catheter-directed thrombolysis of thrombus in patients affected by acute arterial and venous thromboembolic conditions. Our innovative technology platform is easy to use and helps physicians treat their patients through creative interventional procedures. Our devices help 3 physicians restore blood flow immediately with very beneficial effects on thrombotic occlusive disease of the vasculature.