LimFlow Completes Enrollment in PROMISE II Pivotal Trial of Treatment for CLTI

March 15, 2022—LimFlow SA, a Paris, France–based developer of minimally invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), announced today that it has completed patient enrollment in the PROMISE II pivotal trial of the LimFlow system. The company also announced completion of enrollment in the CLariTI study.

According to the company, the LimFlow system is designed to re-establish arterialization in deep veins for patients who have exhausted other methods and face major amputation of their lower limbs.

PROMISE II is a multicenter, prospective, single-arm study in the United States. Using an adaptive statistical design, the study enrolled 105 patients with no-option CLTI. An independent physician committee determined that the patients were no longer eligible for conventional endovascular or surgical therapy to treat CLTI. Endpoints include amputation-free survival at 6 months, limb salvage, and wound healing. Patients will be followed out to 3 years.

The PROMISE II trial’s Principal Investigator is Daniel Clair, MD. Dr. Clair is Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences in Nashville, Tennessee.

“The PROMISE II investigators are very encouraged by our experience using the LimFlow system to treat CLTI patients with no other options,” commented Dr. Clair in the company’s press release. “These are likely the sickest patients ever to have been enrolled in a limb salvage trial.”

Dr. Clair continued, “Major amputations have a devastating effect on the lives of patients and their families. We are excited about the prospect of helping improve the lives of more of these patients once this novel technology becomes broadly available.”

CLariTI is a prospective, observational, multicenter study composed of approximately 200 high-risk and no-option CLTI patients. Investigators will track the clinical progression of CLTI and incidence of death, amputation, and revascularization attempts in patients undergoing standard medical management for the disease over a 1-year period.

Anahita Dua, MD, vascular surgeon at Massachusetts General Hospital and Assistant Professor of Surgery at Harvard Medical School in Boston, Massachusetts, serves as CLariTI Principal Investigator.

“Despite suffering from the most advanced form of CLTI, these no-option and high-risk patients have been excluded from other trials,” commented Dr. Dua in LimFlow’s press release. “Our hope is that the CLariTI study gives us better insights into the reintervention, amputation, and death rates in no-option and high-risk patients treated with the current standard of care.”

The LimFlow system received the CE Mark approval and is currently available commercially in Europe. It has not been approved for sale in the United States, Canada, or Japan, advised the company.