The FDA is reviewing findings, officials hope approval comes soon
University Hospitals is leading a clinical trial that offers a limb-saving option to people who were told amputation is the only route.
By: Jessi Schultz Posted at 7:24 PM, Mar 29, 2023 and last updated 6:05 PM, Mar 29, 2023
CLEVELAND — University Hospitals is a part of a medical break-through. The hospital system is leading the push for a therapy used to save limbs that would otherwise have to be amputated.
University Hospitals and Dr. Mehdi Shishehbor, the president of the Harrington Heart & Vascular Institute, revealed the results of a clinical trial and research that could be life-changing for people suffering from peripheral artery disease.
“This alternative is something that we’ve all been looking for and we’re excited that, now, we’ll have a specific technology that can help us to prevent amputation,” said Shishehbor.
Shishehbor is known as the limb-saver and is committed to preventing amputation.
“It should be the last resort and patients should seek a second, third opinion,” he said. “The most difficult part of my job is to tell a patient that we have no hope, that you need an amputation.”
He often sees people with diabetes and peripheral artery disease who have a lack of circulation in the lower extremities, causing wounds that lead to ulcers, gangrene and necrosis.
The standard of care to fix the lack of blood flow is bypass surgery, or an endovascular approach, but if those don’t work, the result is amputation.
Six years ago, after a vacation in Florida, Cynthia Elford was told her only option was amputation. She has Type-1 Diabetes and an artery condition that can lead to poor circulation in her legs.
“I got a sunburn on the tip of my toe on my left leg and it just wouldn’t heal and wouldn’t heal. It became necrotic and it was just really bad,” she said. “The pain was terrible.”
She said she accepted that she needed to get an amputation.
“Up to today, before this research, those patients ended up with an amputation. You had no hope,” said Shishehbor.
But when she arrived at Shishehbor’s office just a year later, after cutting her toe on the other foot with a pair of nail clippers, she was told again that she would have to amputate her one remaining foot.
“I do know that, I just, I don’t think I could have made it. I think I would have given up if I had to have lost that leg,” she said.
She said it was Shishehbor who looked for other options besides amputation and fought for her to be a part of a new clinical trial that used LimFlow technology to prevent amputation.
The procedure bypasses blocked arteries in the leg and rushes blood back into the foot through the veins. Elford was the first to undergo the procedure in Ohio.
“I’ll never forget, I remember laying in the room, the O.R. room and the nurse came running up and said, ‘He got it. It’s in,’ and I remember people clapping and yelling and so much excitement in that operating room,” she said.
She said adjusting to the therapy was painful, but she’s extremely grateful to have her leg.
The conclusion of the clinical trial shows 76% of patients in the study had success. The FDA is currently reviewing the results of the study and Shishehbor is hopeful LimFlow will be offered to patients nationwide in the next few months.
“There are not too many things in life, as a physician, that is more gratifying and more pleasing than being able to save someone’s life or leg, at least for me,” he said.
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