December 10, 2019
First Patient Enrolled in LimFlow’s PROMISE II United States Pivotal Study
December 10, 2019—LimFlow SA announced that the first patient has been treated in PROMISE II, the company’s United States pivotal trial of the LimFlow percutaneous deep vein arterialization (pDVA) system for the treatment of chronic limb-threatening ischemia (CLTI). The successful first case was performed by Mark Archie, MD, Principal Investigator, and Nina Bowens, MD, subinvestigator for the PROMISE II trial at Harbor-UCLA Medical Center in Los Angeles, California.
PROMISE II is a multicenter, prospective, single-arm study being conducted in the United States and Japan. Using an adaptive statistical design, the study plans to enroll 60 to 120 patients with “no option” CLTI. 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.
In the company’s announcement, Dr. Archie commented, “We are pleased to be the first center in the country to treat a patient in this important trial. The LimFlow system offers a promising new therapy with the potential to restore blood flow to the ischemic foot, heal wounds, and prevent major amputations in a patient population that today is unable to be treated with any current technology.”
In September, the company announced FDA approval of the investigational device exemption for the PROMISE II study of the LimFlow pDVA system. The LimFlow technology is approved for investigational use only in the United States. It has not been approved for sale in the United States, Canada, or Japan. The LimFlow system received CE Mark approval in October 2016 and is currently available commercially in Europe.