LimFlow System Approved by FDA for Treatment of Patients With No-Option CLTI

September 12, 2023—LimFlow SA, a developer of minimally invasive technology for the treatment of chronic limb-threatening ischemia (CLTI) in peripheral artery disease, announced that the FDA has approved the LimFlow system for patients who have CLTI with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

The LimFlow system is designed for transcatheter arterialization of deep veins to reestablish blood flow. The LimFlow system received the CE Mark and is available commercially in Europe. It has not been approved for sale in Canada or Japan, advised the company.

According to the company, FDA approval was based on successful outcomes seen in the PROMISE II United States pivotal trial and from positive clinical results seen in earlier studies. In PROMISE II, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time after LimFlow treatment.

Mehdi Shishehbor, DO, and Daniel Clair, MD, serve as Coprincipal Investigators of PROMISE II.

In March 2023, Limflow announced the publication of the PROMISE II study results by Dr. Shishehbor et al in The New England Journal of Medicine (388:1171-1180). In November 2022, Dr. Clair presented the 6-month findings during the Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation in Las Vegas, Nevada.

“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,” commented Dr. Clair in the company’s press release. “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.”