New Britain, PA, January 10, 2024 –Thrombolex, Inc., a medical device company that develops innovative devices for the treatment of arterial and venous thromboembolic diseases, announces an expansion of the existing product line with the new BASHIR™ .035 and BASHIR™ S-B .035 Endovascular Catheters, which are comparable with an 0.035” guidewire. The BASHIR™ and BASHIR™ S-B Endovascular Catheters are 510(k) cleared for the treatment of acute pulmonary embolism (PE). This FDA clearance was based upon the positive results from the pivotal RESCUE Study, which was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (Grant # R44HL151032-03) and the Commonwealth of Pennsylvania’s Department of Health.
The BASHIR™ catheters resolve thrombus through pharmacomechanical lysis (PML). Targeted thrombolysis are delivered from the expandable infusion basket directly into the clot enabling the immediate restoration of blood flow and optimal resolution of thrombus. This results in a highly effective treatment with ease of placement, shorter procedure time, and superior safety.
Dr. Triston Smith and Dr. Gregory Suero, Interventitional Cardiologists (Trinity Medical Center West, Steubenville, Ohio), said, “Catheter-based pulmonary embolism management should be simple, safe, and effective. The BASHIR™ Endovascular Catheter, with its unique and innovative design, exceeds expectations in those three categories. The 0.035” wire compatibility simplifies the procedure even more and places the BASHIR™ Endovascular Catheter as the premier catheter for the management of this patient population.”
The BASHIR™ Catheters are now available in 7F and 8F sizes. For further information or to schedule a representative visit, please contact Customer Service at 844.792.6300.