A minimally invasive treatment known as transcatheter arterialization can help limit the risk of above-ankle amputation among patients with chronic limb-threatening ischemia (CLTI), according to new findings published in the New England Journal of Medicine.[1]
“This procedure is the only option for a subset of patients with severe vascular disease who are at risk for amputation of their limbs,” Daniel Clair, MD, chair of the department of vascular surgery at Vanderbilt University Medical Center, said in a prepared statement. “Patients with long-standing diabetes and severe vascular disease in the foot itself often have no way to restore enough blood flow to the foot to heal wounds.
The PROMISE II trial included data from 105 patients presenting with CLTI. The median patient age was 70 years old, and 31.4% were women. All patients were treated with the LimFlow System.
Overall, transcatheter arterialization of the deep veins was successful in 99% of patients. The study’s primary endpoint, amputation-free survival after six months, was seen in 66.1% of patients. Also, the treatment was linked to a 76% limb salvage rate and significant reductions in patient pain.
Reducing the risk of amputation is critical for these patients, as nearly half of patients with CLTI who undergo an above-ankle amputation are expected to die within five years.
“Now the majority of these patients can have their limbs and their independence saved with this approach to further reduce the risk of amputation for patients with vascular disease,” Clair added.
LimFlow, the company behind the transcatheter arterialization technique, did fund this analysis. LimFlow CEO Dan Rose commented on the PROMISE II results in a separate statement.
“Too often, patients are confronted with the limits of traditional interventional options and must undergo a major amputation, which often leads to severe complications, greatly reduced quality of life, and an early death,” Rose said. “The LimFlow System demonstrated remarkable success in relieving patients’ pain and healing their wounds, diverting them from amputation and putting them on a path towards a better life. We want to thank the clinical investigators and their research teams for their commitment to this important research. As this is a large and growing patient population in great need of a new therapeutic option, we look forward to engaging further with the FDA as we seek regulatory approval.”
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.