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

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

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 ( 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.



Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.