Twelve-month data from the full patient cohort in the PROMISE I study of the LimFlow percutaneous deep vein arterialization (pDVA) system have been published in the Journal of Vascular Surgery.
Results showed sustained positive outcomes for both amputation-free survival and wound healing. The minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in chronic limb-threatening ischemia (CLTI) patients who are facing major amputation and have exhausted all other therapeutic options.
PROMISE I is a multicenter, prospective, single-arm study of the LimFlow system. It was conducted at seven U.S. centers and enrolled 32 end-stage—or “no option”—CLTI patients, 100% of whom had non-healing wounds on the target foot, 69% of whom had diabetes, and 34% of whom 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.
“The publication of the PROMISE I results in the Journal of Vascular Surgery further validates the benefits of the LimFlow system,” said Daniel Clair, MD, PROMISE I principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Prisma Health-USC Medical Group in Columbia, South Carolina. “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.”
In the PROMISE I study, 70% of patients achieved amputation-free survival at 12 months following 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%.
“Given the unacceptable rates of major amputations globally we are encouraged by the publication of the 12 month PROMISE I data in the prestigious Journal of Vascular Surgery,” said LimFlow CEO Dan Rose. “We are making great strides in our currently enrolling PROMISE II pivotal trial in the U.S. and Japan, and we look forward to advancing our mission of leaving no limb left behind.”