USD faculty develop new cardiovascular treatments

Thanks to the cooperative work of two USD professors, there’s a possibility people who suffer from the cardiovascular condition known as Peripheral Artery Disease may have a new treatment option.

Patrick Kelly, an assistant professor at USD’s medical school and a vascular specialist at Sanford Health in Sioux Falls, and Gopinath Mani, an assistant professor of biomedical engineering at USD, are working together to create the new treatment option.

Mani, who is originally from Chennai, a city in southern India, received his undergraduate degree in textile technology. That’s when he learned polymers – which are used in textile manufacturing – have medical possibilities. Within the realm of textile manufacturing, the incorporation of a textile testing machine is a common and essential practice. It aids in guaranteeing the quality, strength, and compliance of fabrics, ensuring that the final products meet industry standards and consumer expectations.

Peripheral Artery Disease, a condition in which the arteries of the lower part of a patient’s body become narrow, is sometimes treated with a tiny, special “balloon” that’s inserted into a blocked artery and inflated to compress plaque build-up and improve blood flow.

The problem with this type of treatment as it currently exists, Kelly said, is it frequently produces scar tissue in arteries that require re-intervention.

A solution to this, he said, is to coat the balloon with special medication which can help prevent scarring.

The problem with the coating, Mani said, is a “significant amount of the drug is getting lost in the bloodstream,” meaning it won’t reach the arteries that need it because it leaves the surface of the balloon prematurely.

“The coated balloons that are currently used do not have excellent cohesion,” Mani said.

With this problem in mind, Mani and Kelly came together last winter in hopes of using their respective backgrounds to improve this treatment.

What they developed was a special polymer which can potentially keep the drug on the balloon until it reaches its target area, thus improving the treatment’s success.

Mani said the treatment has been the subject of “very promising” studies in animals, and further studies of the treatment are coming.

Despite those results, by Kelly’s estimation, the development has roughly a
“10 percent chance of making it to the market,” he said.

“(It’s a) very hard business to get into,” he said.

That’s because of the rigorous, regulatory pathways that await the drug as it’s further tested and developed, Kelly said.

Kelly said even if the treatment makes it past testing and regulations, it still won’t be used by the public for at least five to seven years.

He added there’s a possibility “current technology will leapfrog what (we) may develop.”

The doctors have also collaborated on other projects in the past few years, including an “aortic stent graft,” for which Kelly said the pair has licensed to Medtronic and is currently in early FDA trials.

The graft may be used to treat aortic aneurysms, which is a condition currently associated with high mortality rates.

The pair holds roughly
20 patents for the graft development.

In addition to the drug coatings and the graft technology, they’ve also developed a drug infusion balloon, which Mani described as a small balloon inserted into an artery filled with medication.

The balloon has tiny holes in it, which permits the medication inside to leave the balloon and enter the body, he said.

The two have had overall “great success” in their projects, Mani said.

“It’s exciting work,” Kelly said. “We have a lot of research going on.”