Thrombolex Receives FDA Clearance for Bashir Endovascular Catheters
May 13, 2019—Thrombolex, Inc. announced FDA 510(k) clearance for the Bashir endovascular catheter (BEC) and the Bashir N-X endovascular catheter (BEC N-X). The BEC and BEC N-X are currently only available in the United States. Plans for distribution outside the United States are forthcoming.
According to the company, the BEC is cleared for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The BEC N-X is cleared for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature.
The BEC incorporates a physician-controlled distal segment with six expandable miniature infusion catheters to deliver fluids to precise locations. The platform technology was developed by Riyaz Bashir, MD, Professor of Medicine and Director of Vascular and Endovascular Medicine at Temple University Hospital in Philadelphia, Pennsylvania.
In the company's press release, Dr. Bashir commented, “My inspiration for the BEC platform technology was to develop a device that I hoped would provide better treatment outcomes by rapid restoration of blood flow through the thrombus, thereby enhancing both endogenous and exogenous fibrinolysis. Acute venous thromboembolic disease has become a significant public health concern in the United States, with approximately 900,000 patients diagnosed and causing up to 100,000 deaths each year.”
Thrombolex advised that the company recently received FDA clearance to begin an early feasibility study to demonstrate the safety and feasibility of the BEC platform technology in the treatment of acute pulmonary embolism (PE). The protocol requires the use of the platform's expandable miniature infusion catheters to deliver low doses of recombinant tissue plasminogen activator directly into an acute PE. The goal of this treatment is to minimize the risk of major bleeding complications, including intracranial hemorrhage, associated with systemic lytic administration.
Additional clinical data will provide new insights into the advantages of rapid restoration of blood flow. Thrombolex believes that harnessing the endogenous lytics in the patient’s own blood in a synergistic manner with a lower dose of exogenous lytic has the potential to accelerate clot lysis and more effectively reduce the total thrombus burden. This should reduce the incidence of chronic pulmonary thromboembolic disease and postthrombotic syndrome, stated the company.