LimFlow System Demonstrates Excellent Sustained Amputation-free Survival and Wound Healing at 1 Year in PROMISE I U.S. Study

November 6, 2020

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 presentation of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow Percutaneous Deep Vein Arterialization System, showing sustained positive outcomes for both amputation-free survival and complete wound healing.

LimFlow notes the results were presented in the Late-Breaking Data session at the VIVA Conference by 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 12-month results from the PROMISE I study show that 70 percent of patients achieved major amputation-free survival, similar to what was seen at six months, following treatment with the LimFlow System. The very challenging patients in the trial also had 75 percent of their wounds classified as healed or healing one year after treatment. Technical success was reported at 97 percent.

“One-year outcomes demonstrate that the benefits from treatment with the LimFlow System are durable,” said Dr. Clair. “One of the greatest challenges in the treatment of CLTI is to achieve long-lasting outcomes due to disease progression. In this study, the vast majority of patients who would otherwise be facing major amputation were able to avoid it and, at the same time, heal their previously non-healing wounds. This type of lasting result in such a challenging, no-option patient population offers tremendous hope to CLTI patients and the physicians who treat them.”

PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System conducted at seven U.S. centers encompassing 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. 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.

“We continue to be gratified about the number of patients in our clinical studies who are benefitting from the LimFlow System,” said LimFlow CEO Dan Rose. “Recognizing that most of these patients may have lost their limbs, and even their lives, without our technology drives all of us at the company, every day. We are excited about the clinical progress we are making and look forward to continuing to bring a better quality of life to patients who otherwise have little hope.”

The pivotal PROMISE II clinical trial of the LimFlow System is currently enrolling patients at centers across the U.S.

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.