In a significant development a US-based Kashmir doctor has invented two Endovascular Catheter devices for treating acute Venous Thromboembolic, a blood clotting disorder which results in deaths across the globe. Dr Riyaz Bashir has become the first medico across the world to achieve the rare feat which can help save thousands of lives. Last week, the US Food and Drug Administration (FDA) granted premarket notification clearance for the catheters invented by Dr Bashir, MD, FACC, RVT. This clearance now allows Thrombolex to commercialize the catheters. Dr Bashir is a co-founder and has equity interest in Thrombolex, Inc, a medical device company partnered to Temple University.
The Bashir Endovascular Catheter (BEC) has been cleared for the controlled and selective infusion of fluids, including clot-dissolving medications, into the veins and arteries of the peripheral vasculature. “The BEC is unique because it’s the only catheter of its kind that, once advanced into the clot, can be expanded by the physician into six expandable mini-catheters to deliver medications in precise locations throughout the cross section of the clot,” a press statement by Temple University said. Alumni of Government Medical College (GMC) Srinagar Dr Riyaz is Professor of Medicine at Lewis Katz School of Medicine at Temple University (LKSOM) and Director of Vascular and Endovascular Medicine at Temple University Hospital, and Nicholas Green, Director of Research & Development at Thrombolex. “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 blood clot thereby enhancing the breakdown of the clot,” said Dr Bashir. “Acute Venous Thromboembolic (VTE) disease, which is marked by blood clots that start in a vein – often in the deep veins of the leg, groin or arm – and can break off and travel to the lungs causing a pulmonary embolism, has become a significant public health concern in the U.S. Approximately 900,000 patients have been diagnosed with VTE and it causes up to 100,000 deaths each year, according to the CDC.” Quoting Marvin Woodall, Chairman and CEO and co-founder of Thrombolex, the statement said, “Our dedicated team is proud to have received FDA clearance for these two unique catheter-directed thrombolysis products to be used in the treatment of patients suffering from acute VTE disorders.”
Thrombolex has also received FDA approval to begin a multicenter early feasibility study in the clinical setting to evaluate the safety and feasibility of the Bashir Endovascular Catheter in the treatment of acute pulmonary embolism. The statement further said that the Bashir N-X Endovascular Catheter (BEC N-X) is cleared for the controlled and selective infusion of fluids chosen by the physician into both the peripheral and pulmonary vasculature, which is comprised of the blood vessels of the lungs. Unlike the BEC, the BEC N-X is not expandable.