LimFlow System Evaluated in PROMISE I for Treating CLTI

May 20, 2021—LimFlow SA announced that the 12-month data from the full patient cohort in its PROMISE I early feasibility study of the LimFlow percutaneous deep vein arterialization (pDVA) system have been published by Daniel G. Clair, MD, et al in the Journal of Vascular Surgery.

The company stated that the results showed sustained positive outcomes for both amputation-free survival and wound healing. The LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in patients with chronic limb-threatening ischemia (CLTI) who are facing major amputation and have exhausted all other therapeutic options.

According to the company, PROMISE I is a multicenter, prospective, single-arm study of the LimFlow system conducted at seven centers in the United States. Investigators enrolled 32 end-stage—or “no option”—CLTI patients, of whom 100% had nonhealing wounds on the target foot, 69% had diabetes, and 34% had renal insufficiency. No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons.

In the PROMISE I study, 70% of patients achieved amputation-free survival at 12 months after treatment with the LimFlow system, and 75% had all wounds classified as healed or healing at 12 months as adjudicated by an independent core lab. Technical success was reported at 97%, noted LimFlow.

Dr. Clair, who is principal investigator of the study, commented in the company’s press release, “The publication of the PROMISE I results in the Journal of Vascular Surgery further validates the benefits of the LimFlow system. The LimFlow pDVA system was effective in treating no-option CLTI resulting in a high percentage of treated patients healing their wounds and surviving free of major amputation at 12 months.”

The company advised that the LimFlow system received CE Mark approval in October 2016 and is currently available commercially in Europe. In the United States, the LimFlow technology is approved for investigational use only. The device has not been approved for sale in the United States, Canada, or Japan.