Six-Month Data From PROMISE I Presented for LimFlow System to Treat CLTI
November 6, 2019—LimFlow SA announced the presentation of positive 6-month data from the full patient cohort in the PROMISE I early feasibility study of the LimFlow percutaneous deep vein arterialization system. The results were presented by Daniel Clair, MD, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The LimFlow system is intended for the treatment of chronic limb-threatening ischemia (CLTI) when all other therapeutic options have been exhausted and a patient with CLTI is facing major amputation.
According to the company, PROMISE I is a multicenter, prospective, single-arm study conducted at seven centers in the United States. The study is composed of 32 end-stage (“no option”) CLTI patients, 100% of whom had nonhealing wounds on the target foot, 69% of whom had diabetes, and 34% of whom had renal insufficiency.
At 6 months, the LimFlow system achieved an amputation-free survival rate of 74%. A strong trend of successful wound healing was also demonstrated, with 67% of wounds classified as healed or healing at 6 months and 100% healed or healing at 9 months. Technical success was 97%.
Dr. Clair commented in the company’s announcement, “Findings from this early feasibility trial are very promising. They show that the LimFlow system is a novel, safe, and reproduceable approach for improving wound healing and reducing amputation rates in a patient population for whom amputation would otherwise be considered inevitable. It is very encouraging to be able to offer hope to patients that cannot be treated with any current technology today.”
Dr. Clair is Chair of the Department of Surgery at the University of South Carolina (USC) and Palmetto Health-USC Medical Group in Columbia, South Carolina. He serves as the Principal Investigator of the PROMISE II pivotal trial, which the FDA approved in September to evaluate the LimFlow percutaneous deep vein arterialization system.
The LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation, noted the company.
The company advised that the LimFlow system received CE Mark approval in October 2016 and is currently available commercially in Europe. It has not been approved for sale in the United States, Canada, or Japan. The LimFlow technology is approved for investigational use only in the United States.