Fewer diabetes and peripheral artery disease patients may lose their lower legs to amputation if a drug-coated balloon invented at Sanford Health and the University of South Dakota works as designed.
Startup company Tailored Medical Devices, located in the USD Discovery District in Sioux Falls, South Dakota, has licensed the balloon and is raising money to further develop and test it. The device, one of two developed in a collaboration between Sanford Health and USD, may more precisely deliver drugs to specific arteries.
It’s based on intellectual property jointly created by Sanford Health vascular surgeon and inventor Patrick Kelly, M.D., and Gopinath Mani, Ph.D., formerly of USD. Other contributing inventors include Tyler Remund at Sanford Health and Sujan Lamichhane and Jordan Anderson, also formerly of USD.
“If you’re working on people who are already going to lose their leg if you do nothing, all you can do is help them. This hopefully will expand our ability to help them,” Dr. Kelly said.
Because the arteries in lower legs are small, surgeons have only a couple of options to clean out plaque and get blood flowing freely again. After a procedure such as angioplasty, this drug-coated balloon would deliver medication that reduces the scar tissue that can, over just a few months, re-narrow the artery to as small as it was before. That often requires the patient to endure a repeat of the treatment.
“We go in and clean out an artery. That by nature starts an inflammatory process. Even though we’re fixing it, we’re traumatizing it,” Dr. Kelly said of the healing process. “Drug-coated balloons try to deliver a medication that inhibits that scar tissue formation.”
And that could prevent future re-narrowing of those arteries.
‘It would be limb saving’
Most drug-coated balloons on the market are for above-the-knee treatments only. This new device is unique because it uses a special polyethylene oxide coating to time the release of the medication from the balloon to the artery. That prevents the release of the drug while tracking to the target site and allows for treatment in multiple areas.
“You could treat arteries that are currently not being treated. And if this technology works the way we think it will, we may also be able to use fewer of these costly balloons,” Dr. Kelly said. “We think it may be kinder and gentler.”
Ryan Rykhus, Tailored Medical Devices’ research and development engineer, joined the startup while working on his doctorate in biomedical engineering at USD.
He said “it would be limb saving” for many of the 83,000 Americans who undergo a procedure each year to increase blood flow to the lower legs. About half of these patients must repeat the currently used procedure because of re-narrowing of the arteries.
“This device really has a potential to be a life-changing therapy for a lot of people that could be losing their lower limbs,” Rykhus said of many of the 75,000 Americans who undergo an amputation every year because of vascular disease. “Treatments exist for below-the-knee peripheral artery disease. There’s just a consensus that they’re not good enough. We can be doing better. That’s the goal. We want to bring technology that’s been the gold standard for above-the-knee into more patients.”
Which means a better quality of life for people, especially as they age.
“Mobility and accessibility are really important things,” Rykhus said. “Being able to restore that mobility and enjoy life and giving them opportunities to spend time with kids and grandkids, that is something that’s really rewarding.”