PUBLICATION OF ONE YEAR OUTCOMES FROM PROMISE I U.S. STUDY OF THE LIMFLOW SYSTEM DEMONSTRATES EXCELLENT SUSTAINED AMPUTATION-FREE SURVIVAL AND WOUND HEALING IN PATIENTS WITH NO-OPTION CHRONIC LIMB-THREATENING ISCHEMIA
Twelve-Month Results Published in the Journal of Vascular Surgery
Paris, May 20, 2021 — LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow Percutaneous Deep Vein Arterialization System 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 CLTI patients who are facing major amputation and have exhausted all other therapeutic options.
PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System conducted at seven U.S. centers and enrolled 32 end-stage – or “no option” – CLTI patients, 100 percent of whom had non-healing wounds on the target foot, 69 percent of whom had diabetes and 34 percent 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. “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 percent of patients achieved amputation-free survival at 12 months following treatment with the LimFlow System, and 75 percent had all wounds classified as healed or healing at 12 months as adjudicated by an independent core lab. Technical success was reported at 97 percent.
“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 US and Japan, and we look forward to advancing our mission of leaving no limb left behind.”
CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.
About LimFlow SA
LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia (CLTI), a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population. For more information on the company and the LimFlow pDVA System, visit www.limflow.com.
CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.