Bashir Endovascular Catheter First-In-Human Trial for Acute Pulmonary Embolism Confirms Early Safety and Feasibility and Impressive Reduction of Clot Burden

Thrombolex Reports Data Showed a Significant Reduction in Right Ventricular to Left Ventricular (RV/LV) Diameter Ratio and Clot Burden

Thrombolex, Inc. is a medical device company that focuses on the design, development and manufacture of innovative endovascular therapies for the treatment of arterial and venous thromboembolic disorders.

Recently they 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 was presented at the American Venous Forum (AFV) Annual Meeting in Amelia Island, FL.  The data showed a significant reduction in right ventricular to left ventricular (RV/LV) diameter ratio and clot burden.

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 notes, “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.” He added, “I look forward to seeing what this device can do in a larger study and a randomized cohort.”

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy