US nod for Indian doctor’s invention

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Dr bashir endovascular catheter

Two catheters originally developed by Temple Cardiologist Dr Riyaz Bashir get pre-market clearance by the FDA for dissolving blood clots

“Applied for patent protection in multiple countries including India,” says Dr Bashir.

A US-based doctor of Indian origin has invented two catheters which can treat the blood clotting disorder—Acute Venous Thromboembolic (VTE) — known to have a high mortality rate worldwide. He is the first medico to have achieved this rare feat.

Dr Riyaz Bashir, who is the alumnus of Government Medical College (GMC) Srinagar, has already received pre-market notification clearance from the U.S. Food and Drug Administration (FDA) for the two EndovascularCatheter devices named as The Bashir™ Endovascular Catheter (BEC) and The Bashir N-X™ Endovascular Catheter (BEC N-X) by his company Thrombolex.inc.

VTE disorders

“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,” Marvin Woodall, Chairman and CEO and co-founder of Thrombolex told Temple Health, a journal of Temple University Lewis Katz School of Medicine.

Dr Bashir, who is also the Director of Vascular and Endovascular Medicine at Temple University Hospital, says the devices have the potential to revolutionize the treatment of massive and sub-massive Pulmonary Embolism and iliocaval Deep Vein Thrombosis.

“More than 2 billion dollars are spent in the US alone in treating the long term complications of VTE. So it is very important that we treat these conditions early on before these complications occur in these patients and markedly impair their quality of life,” he told Healthwire.

“My hope is that it will help all patients and save them extra expenses. We have applied for patent protection in multiple countries, including India. I hope that all patients no matter where they live, get the benefit from this innovation,” Dr Bashir says.

According to him, the use of old devices during endovascular procedures made thrombus removal difficult as it had “high risks of bleeding” in Acute Pulmonary Embolism (PE) and iliocaval deep vein thrombosis (DVT)cases.

“Earlier the procedures would also lead to chronic thromboembolic pulmonary hypertension and post-thrombotic syndrome if these blood clots stayed there. It pushed me to develop the device which will make the thrombus removal in large vessels effective,” he says. 

Dr Bashir says the former president of Johnson and Johnson’s Interventional systems, Marvin Woodall, guided him to develop a prototype of the device and form the company called Thrombolex Inc, which has been founded in partnership with Temple University. 

Bashir Endovascular Catheter

“It took me three-and-a-half years to invent Endovascular Catheter devices, which have been approved after various tests by medical experts.”

“The novel interventional catheter was awarded the first prize at the American Heart Association’s Innovation Challenge in Philadelphia in 2016. Since then we have performed multiple benches and animal tests including a proof of concept test in an animal model of caval thrombosis. Based on these tests we froze the design for the Bashir Endovascular Catheter and successfully received an FDA clearance on February 25, 2019, to market this device for use in peripheral circulation,” he says.

As per the Temple Health journal, the Bashir™ Endovascular Catheter (BEC) is cleared for the controlled and selective infusion of fluids, including clot-dissolving medication, 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,” it states.

It says the second catheter, Bashir N-X™ Endovascular Catheter (BEC N-X) is also cleared for the controlled and selective infusion of fluids chosen by the physician into both the peripheral and pulmonary vasculature, which comprises blood vessels of the lungs. “Unlike the BEC, the BEC N-X is not expandable.”

Dr Bashir, a native of Kashmir’s Rawalpora area in Srinagar, says the severity of Venous Thromboembolic (VTE) diseases worldwide also motivated him to research in this field.

Inspiration

“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,” he says.

“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,” he says adding that the disorder causes up to 100,000 deaths each year, according to the CDC

Blood clotting is the third common cause of death

Dr Bashir says that the blood clotting is the third common cause of death after heart attacks and strokes worldwide and he hoped his devices will help to treat this dreadful disease.

He claims that every one to two patients per 1000 population in the USA develops this problem. 

“It is widely seen among women who take birth controlling medicines. In most of the cases the clotted blood moves towards the lungs and complicates the situation of the patient,” he says.

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