University Hospitals Health System Inc.
10/29/2025 | Press release | Distributed by Public on 10/29/2025 07:06
University Hospitals Research Published in New England Journal of Medicine Shows Durability of Limb Salvage Therapy for No-Option Amputation Patients
CLEVELAND - An update in the October 30, 2025 issue of the New England Journal of Medicine has shown that transcatheter arterialization of the deep veins (TADV) using the LimFlow System is a reliable and long-lasting therapy helping patients with chronic limb-threatening ischemia (CLTI), the most severe form of peripheral artery disease, avoid amputation.
TADV is a procedure designed to bypass blocked arteries in the leg and send blood back into the foot through the veins. The PROMISE I and PROMISE II U.S. clinical trials studied TADV using the LimFlow System.
Results from the PROMISE II U.S. pivotal clinical trial published in NEJM in March 2023 found that at six months post-procedure, 76 percent of patients were able to keep their leg (also called limb salvage). Within that same period, 76 percent of patients experienced completely healed or healing wounds.
Now, University Hospitals Harrington Heart & Vascular Institute is reporting the two-year results from the PROMISE I and PROMISE II trials. Out of 137 study participants, 68 percent experienced limb salvage at two years post-procedure. Eighty-two percent of patients healed or had healing wounds.
"We are thrilled that patients who receive LimFlow therapy generally continue to do well after two years," said Mehdi Shishehbor, DO, MPH, PhD, President of UH Harrington Heart & Vascular Institute; Angela and James Hambrick Distinguished Chair in Innovation; and lead author and co-principal investigator of the study. "Many, if not all of these patients would have suffered from chronic wounds or would have been scheduled for a major amputation without enrollment in this study. The fact that 68 percent kept their leg two years later makes it very clear that TADV with LimFlow is a powerful tool for avoiding amputation."
The Amputee Coalition of America estimates more than 500 patients undergo an amputation every day. Around 30 percent of amputees experience depression or anxiety. Amputees can have "phantom pain" in the missing limb that causes stabbing, burning or shooting sensations.
An estimated two million Americans may be living with CLTI, and for many with comorbidities like diabetes, traditional treatments may not be feasible or may have already been exhausted. For these patients with no other options, the limb begins to turn black and die, and amputation may become imminent. Nearly half of all patients with vascular disease will die within five years after amputation. That's higher than the five-year mortality rates for breast cancer, colon cancer, and prostate cancer.
"It's estimated an astounding 3.6 million people will be living with potential limb loss by 2050," said Dr. Daniel Simon, cardiologist and President, Academic & External Affairs and Chief Scientific Officer, Ernie and Patti Novak Distinguished Chair in Health Care Leadership, University Hospitals. "Patients and families can feel hopeful and reassured after seeing these continued positive results that amputation can be avoided."
Outcomes from the PROMISE I and PROMISE II trials led to the FDA approval of the LimFlow System as a limb salvage therapy in September of 2023. It is now clinically available across the U.S. and EU, giving thousands of patients hope for an alternative to limb loss.
TADV is a procedure designed to bypass blocked arteries in the leg and send blood back into the foot through the veins. The PROMISE I and PROMISE II U.S. clinical trials studied TADV using the LimFlow System.
Results from the PROMISE II U.S. pivotal clinical trial published in NEJM in March 2023 found that at six months post-procedure, 76 percent of patients were able to keep their leg (also called limb salvage). Within that same period, 76 percent of patients experienced completely healed or healing wounds.
Now, University Hospitals Harrington Heart & Vascular Institute is reporting the two-year results from the PROMISE I and PROMISE II trials. Out of 137 study participants, 68 percent experienced limb salvage at two years post-procedure. Eighty-two percent of patients healed or had healing wounds.
"We are thrilled that patients who receive LimFlow therapy generally continue to do well after two years," said Mehdi Shishehbor, DO, MPH, PhD, President of UH Harrington Heart & Vascular Institute; Angela and James Hambrick Distinguished Chair in Innovation; and lead author and co-principal investigator of the study. "Many, if not all of these patients would have suffered from chronic wounds or would have been scheduled for a major amputation without enrollment in this study. The fact that 68 percent kept their leg two years later makes it very clear that TADV with LimFlow is a powerful tool for avoiding amputation."
The Amputee Coalition of America estimates more than 500 patients undergo an amputation every day. Around 30 percent of amputees experience depression or anxiety. Amputees can have "phantom pain" in the missing limb that causes stabbing, burning or shooting sensations.
An estimated two million Americans may be living with CLTI, and for many with comorbidities like diabetes, traditional treatments may not be feasible or may have already been exhausted. For these patients with no other options, the limb begins to turn black and die, and amputation may become imminent. Nearly half of all patients with vascular disease will die within five years after amputation. That's higher than the five-year mortality rates for breast cancer, colon cancer, and prostate cancer.
"It's estimated an astounding 3.6 million people will be living with potential limb loss by 2050," said Dr. Daniel Simon, cardiologist and President, Academic & External Affairs and Chief Scientific Officer, Ernie and Patti Novak Distinguished Chair in Health Care Leadership, University Hospitals. "Patients and families can feel hopeful and reassured after seeing these continued positive results that amputation can be avoided."
Outcomes from the PROMISE I and PROMISE II trials led to the FDA approval of the LimFlow System as a limb salvage therapy in September of 2023. It is now clinically available across the U.S. and EU, giving thousands of patients hope for an alternative to limb loss.
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