Revolutionizing a treatment for a deadly disease
Riyaz Bashir, director of vascular and endovascular medicine at Temple University Hospital, was dissatisfied with the current treatments for pulmonary embolism.
So, he created a new one.
In late December of 2023, Riyaz Bashir returned to his office at Temple University Hospital after a long day in the catheterization laboratory. As he walked in, he noticed an envelope in the mailbox on his door. It was a Christmas card from a woman in Athens, Georgia, whom he had never met or heard of.
“Thanks so much for your invention. It saved my daughter’s life,” she had written.
The message touched Bashir, an interventional cardiologist and director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at the Lewis Katz School of Medicine at Temple University. “I didn’t know the patient, and I didn’t even know the doctor who treated her, but this made my day ... no, my year,” he reflected.
The woman’s daughter had experienced a pulmonary embolism (PE), a serious condition where a blood clot blocks blood flow to the lungs. Her daughter’s life was saved using the BASHIR Endovascular Catheter, a groundbreaking medical device that Bashir had dedicated years to developing.
Science with heart
PE is a global health crisis that affects millions each year and ranks as the third leading cause of cardiovascular mortality, behind heart attacks and strokes.
For Bashir, the battle against PE began with a realization in 2014: The existing treatment technologies were inadequate. He thought he knew why.
The devices used to treat PE were designed for small vessels around 5 mm in diameter, but being used to treat larger vessels of approximately 30 mm.
“We were using a device designed for a very thin clot to treat one ten times that size and expecting the same success rate,” he explained.
He recognized the urgent need for a device explicitly tailored to larger vessels aimed at minimizing the risks associated with high doses of clot-dissolving drugs, which can lead to severe complications like intracranial bleeding.
How it works
The BASHIR Endovascular Catheter expands within a clot, creating multiple fissures and channels and allowing the patient’s own healthy blood to carry the body’s intrinsic clot-dissolving chemicals into the clot. The six limbs of the catheter’s basket open in a spiral motion, a helical twist, that mimics the natural mechanics of a muscle contraction, fissuring the clot. Once the limbs are embedded in the clot, doctors spray a clot-dissolving medicine into the fissures, accelerating clot dissolution until blood flow is restored.
The BASHIR Endovascular Catheter stands out for its remarkable effectiveness. It requires significantly less medication than traditional methods, which reduces the risk of major bleeding or other adverse events and has proven to be two to three times more effective than existing catheter-based treatments.
Furthermore, its user-friendly design allows any cardiologist or interventionalist to operate it. “Using the device is similar to other procedures performed by these specialists daily,” said Bashir. “So, any cardiologist, radiologist or vascular surgeon anywhere in the world can use this technology.”
“The greatest innovations come from love for your patients; it forces you to innovate. If you care for and love your patients, you must find ways to help them.”
How it started
In 2014, at a medical conference, Bashir crossed paths with Marvin Woodall, ex-president of Johnson & Johnson interventional systems. Woodall pioneered multiple medical device developments such as the first coronary stent. Having lost a close friend to the condition, Woodall had a personal stake in tackling PE, and his passion led him to connect Bashir with medical device engineers who might help bring Bashir’s vision to fruition.
The first engineer declined, saying his design couldn’t be accomplished because of highly complex engineering requirements. But another experienced medical device engineer, Nick Green, who now shares the patent for this innovative technology with Bashir, was up to the challenge.
“When Riyaz sent me his preliminary drawings and explained what he wanted to do, I was very excited,” said Green, who had also lost a close friend to a PE. “I told him I would do anything I could to help.” Woodall then brought an additional team member in the fold: Mike Cerminaro, a serial venture capital investor and former co-founding member of BlackRock’s private equity and venture capital investment platform.
Together, they embarked on a journey filled with countless iterations and relentless testing, refining the design based on real-world conditions.
The earliest models and testing were conducted using 3D-printed models of the vena cava—two large veins that return deoxygenated blood from the body to the heart—where many blood clots are lodged. The team also tested the device within clear gel in transparent glass tubes purchased at local hardware stores to enable them to see how the device would perform within a clot. Along the way, they made numerous adjustments and improvements, such as ensuring the limbs of the catheter's expandable infusion basket opened evenly and modifying the activation switch for ease of use.
A close call
In 2016, at the recommendation of Niraj Muni, director of commercialization operations in Temple’s Office of the Vice President for Research, Bashir submitted his invention to the American Heart Association Innovation Challenge, where it won first prize. The recognition ignited significant interest in Bashir’s device, and Temple filed for the patent.
“Our goal is to support Temple researchers at every stage of the commercialization process,” said Muni. “Intellectual property protection is important for encouraging further innovation. When we can advance a product or technology to the marketplace, that’s when we see the benefit to society.”
But, as Bashir tells the story, he almost didn’t submit the application.
“It was due at midnight,” he recounted. “I didn’t finish my last case until 8 p.m., and I fell asleep on my couch after eating dinner and playing with my kids, but my wife woke me up at 10:30 p.m. and nudged me to complete the submission before the deadline.”
Powered by purpose
Fast-forward to today: Two major clinical trials, 36 issued patents, 13 pending patents and eight FDA-approved devices later, the family of BASHIR Endovascular Catheters are being manufactured at a plant in Bucks County, Pennsylvania, by Thrombolex Inc. (in partnership with Peregrine Surgical). Thrombolex is a company Bashir co-founded with Green, Woodall and Cerminaro, which has obtained a worldwide license from Temple University to develop and commercialize the technology.
The clinical trials that were conducted to receive FDA clearance were funded through research grants provided by the National Institutes of Health and the Commonwealth of Pennsylvania Department of Health. The venture promises to both save lives and bring significant economic opportunities to the region.
“That’s one reason why the state of Pennsylvania has been so supportive—in addition to developing a life-saving technology, this is a big manufacturing and job creation opportunity for the state,” said Bashir.
With ongoing efforts to distribute the devices worldwide, he envisions a future where fewer lives are lost to this deadly disease. “The greatest innovations come from love for your patients; it forces you to innovate,” said Bashir. “If you care for and love your patients, you must find ways to help them.”
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