FDA Approves PROMISE II Pivotal Study of LimFlow System to Treat Chronic Limb-Threatening Ischemia


September 19, 2019—LimFlow SA, a France-based developer of minimally invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), announced that the FDA has approved the company’s investigational device exemption for the PROMISE II pivotal study of the LimFlow percutaneous deep vein arterialization system.

PROMISE II is a multicenter, prospective, single-arm study to be conducted in the United States and Japan. The United States pivotal trial is conducted as part of the FDA Breakthrough Devices program, noted the company.

The LimFlow system is intended for when all other therapeutic options have been exhausted and a patient with CLTI is facing major amputation. The device is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins.

According to the company, the study will use an adaptive statistical design to enroll 60 to 120 “no option” CLTI patients. Endpoints include amputation-free survival at 6 months, limb salvage, and wound healing. Patients will be followed out to 3 years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.

LimFlow advised that the approval to initiate the pivotal trial follows completion of the 6-month follow-up of PROMISE I, the United States early feasibility study that enrolled 32 patients at seven centers. Interim outcomes from the first 10 patients treated in the PROMISE I study showed nine patients surviving and amputation-free at 1 year, with seven of those patients experiencing complete wound healing.

These results were presented by Steve Henao, MD, at the New Cardiovascular Horizons Conference held May 29–31 in New Orleans, Louisiana. The complete results of PROMISE I will be presented during the Late-Breaking Trials session at VIVA 2019, the Vascular Interventional Advances annual conference held November 4–7 in Las Vegas, Nevada.

Daniel Clair, MD, the Principal Investigator of PROMISE II, commented in the company’s announcement, “For these late-stage CLTI patients, success can be defined in two ways: wound healing and amputation-free survival. This exciting new therapy has the potential to restore blood flow to the ischemic foot, which may help patients heal their wounds and keep their feet. I am very encouraged by the early experiences in the United States, and outcomes from this pivotal trial may offer hope to the many Americans who might otherwise face major amputations.”


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