FDA approves University Hospitals' therapy to help those at risk of amputation keep their limbs
The U.S. Food and Drug Administration has approved a therapy procedure that can help potential amputees avoid losing their legs.
University Hospitals announced that LimFlow therapy bypasses blockages in arteries of the legs and restores blood flow in patients suffering from chronic limb-threatening ischemia (CLTI), a severe vascular disease caused by peripheral artery disease. Nearly 2 million people are living with limb loss in the United States, according to the Amputee Coalition. Vascular disease is the cause in 54% of those cases.
The approval comes after a study co-led by UH's Harrington Heart & Vascular Institute found that LimFlow therapy enabled most patients treated to keep their leg and experience wound healing, UH said in a media release. The minimally invasive procedure essentially turns a vein into an artery, returning blood back to the foot. The therapy is meant for patients who are facing amputation with no other treatment options.
The new procedure is potentially life-changing, said Dr. Mehdi Shishehbor, president of UH Harrington Heart & Vascular Institute.
"This is huge because ... getting an amputation has significant implications," he said. "First of all, 50% of patients that get amputated die within two years. [There's also] a significant emotional and psychosocial impact from getting an amputation, a major amputation."
For example, recent studies found many patients would rather die than have a limb amputated, Shishehbor said.
"Over 70% of patients said they would rather die than lose their leg," he said. "The patients lose their identity."
Approximately 500 people each day get a limb amputated, with minorities most at risk, according to Shishehbor.
"African-Americans are four times more likely to get amputated as compared to whites when they go to a hospital," he said. "One of the reasons we think this is true is because folks from a lower socioeconomic class, they present in the later stages of the disease when their routine options may not be viable, such as bypass or endovascular."
This new therapy can help address the disparity by providing an option for patients in such dire straits, Shishehbor said.
"I believe that this technology should be able to impact the disparities in amputation," he said. "We can use this technology to offer them hope and save their legs."
However, Shishehbor cautioned that implementation of the new procedure will take time.
"I think it's going to be more slowly because this is a complicated operation," he said. "It requires the extensive team that are involved in taking care of these patients. It's really not about one individual."
This is, for example, in contrast to treatments that rely on medical devices, Shishehbor said.
"It's not like a technology, like a stent that everybody can just buy it and do it," he said. "It is a procedure. So it requires a lot of understanding of a technical aspect, but also the pre- and post-operative care after the procedure is performed."
However, Shishehbor said regardless of the time it takes to broadly implement the procedure, the impact it has on patient health will be significant.
"I think that this technology may be another hope for those patients when in the past they've been hopeless," he said. "They've been told that they need to get a major amputation. And now maybe there is something else that can be offered."