Thrombolex Inc., a medical device company focused on the design, development and manufacture of endovascular therapies for the treatment of arterial and venous thromboembolic disorders, has 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 results from the FIH 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,” Dr. Sista said.
“The amount of thrombus removed with less than 14mg 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.”
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 nine participants across four U.S. study centers.
The Thrombolex FIH study demonstrated excellent safety, as there were no drug or device-related 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 percent reduction, at 48 hours after intervention. Likewise, the Modified Miller Index (MMI) demonstrated a decrease from 25.4 ± 5.3 pre-procedure to 16.0 ± 4.0 at 48 hours (p=0.0005), corresponding to a 37.1 percent reduction, after a mean dose of 13.6mg of r-tPA over eight hours.
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 at Massachusetts General Hospital, said the innovative design of the Bashir Endovascular Catheter enables it to engage and fissure the thrombus, as well as deliver fibrinolytic throughout the entire cross-sectional volume of the clot.
“In theory, this potentially allows for more prompt restoration of flow
to the lungs and relief of right ventricular overload,” Dr. Rosenfield said.
“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. 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, according to Thrombolex Chairman and CEO Marv Woodall.
“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,” Woodall said. “We look forward to collaborating with physicians who work in this field to bring better treatment options to patients.”
Important instructions for use, complete indications, warnings, contraindications and precautions, and information about Thrombolex and the family of Bashir Endovascular Catheters is available on the website at thrombolex.com.
Founded in 2016, Thrombolex is engaged in the design, development, manufacture and distribution of endovascular catheters used in interventional procedures, particularly in catheter-directed thrombolysis of thrombus in patients affected by acute arterial and venous thromboembolic conditions. VTN
