Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition.
France-based LimFlow designed its TADV (transcatheter arterialization of deep veins) system to reestablish blood flow in deep veins. It treats “no-option” CLTI patients who exhausted all other treatment methods. The therapy aims to prevent amputation and the associated complications, mortality and deterioration of quality of life.
This minimally invasive system bypasses blocked arteries in the leg and delivers oxygenated blood back into the foot through the veins.
“At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI,” said CEO Dan Rose. ‘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. 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.”
More about LimFlow, CLTI and how the company won approval
According to a news release, CLTI affects up to four million Americans, disproportionately impacting minority and underserved patients. This condition results in more than 150,000 major amputations per year in the U.S. LimFlow says FDA approval enables access to a minimally invasive treatment that can save limbs and improve lives.
The FDA approval followed positive data from the PROMISE II pivotal trial published earlier this year. Data demonstrated 66% amputation-free survival at six months with the LimFlow system. This exceeded the FDA’s performance goal with statistical significance. More than three-quarters of no-option CLTI patients kept their leg and experienced progressive wound healing, the company said. Many reported significant pain relief during the time following their treatment.
The LimFlow System is the first and only FDA-approved device for TADV. It also holds CE mark approval in Europe.
“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,” said Dr. Daniel Clair, PROMISE II/III co-principal investigator and professor and chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “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.”