FDA approves new minimally invasive CLTI treatment for ‘no-option’ patients at risk of amputation

Michael Walter | September 12, 2023 | Cardiovascular Business | Interventional Cardiology

LimFlow, a medical device company with locations in California and Paris, has gained approval from the U.S. Food and Drug Administration (FDA) for its LimFlow System for Transcatheter Arterialization of Deep Veins. The LimFlow System was designed to help reestablish blood flow in chronic limb-threatening ischemia (CLTI) patients who face a high risk of amputation and have no other endovascular or surgical options available to them.

The device, the first of its kind to gain FDA approval, is already commercially available in Europe.

“At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI. We developed a novel way to make a vein function as an artery with the goal of saving limbs, and by doing that, saving patients’ lives,” LimFlow CEO Dan Rose said in a prepared statement. “We thank the FDA for their collaborative review process, and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

The FDA made its decision largely based on data from the PROMISE II trial, which included 105 “no-option” CLTI patients with a median age of 70 years old. Overall, transcatheter arterialization with the LimFlow device was successful in 99% of patients. The study’s primary endpoint, amputation-free survival after six months, was seen in 66.1% of patients. In addition, treatment was linked to a 76% limb salvage rate and significant reductions in patient pain. The full PROMISE II trial was published in the New England Journal of Medicine.[1]

“With LimFlow, we now have an option for the sickest patients who were previously consigned to limb loss and the downward spiral that accompanies it,” Daniel Clair, MD, co-principal investigator of PROMISE II and chair of the department of vascular surgery at Vanderbilt University Medical Center, said in the same statement. “Using this new treatment, we have seen many patients whose limbs have been saved, whose pain has been reduced or resolved, whose chronic wounds are healed or healing, and who can now look forward to happier and more active lives.”

A video demonstration of the LimFlow System is available here.

New minimally invasive CLTI treatment helps save patients from amputation

Interventional cardiology's role in treating CLI continues to evolve

What do interventional cardiologists need to treat PAD and CLI?

Bypass surgery the best way to limit amputations, death among CLTI patients

Many PAD patients are missing out on vital risk assessments

Michael Walter, Managing Editor

Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

Around the web

Health Exec

Major association of physicians presents itself as a go-to alternative vs. the government on vaccine expertise

One of the most formidable societies of medical professionals in the U.S. is going toe-to-toe with Robert F. Kennedy’s HHS over changing vaccination recommendations.

Health Exec

Tom Price: Medical residency slots need to expand to combat physician shortages

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

Health Imaging

Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.