LimFlow SA, a 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), announced today that it has completed patient enrollment in the PROMISE II pivotal trial of the LimFlow System. The LimFlow System is designed to reestablish arterialization in deep veins for patients who have exhausted other methods and face major amputation of their lower limbs.
PROMISE II is a multi-center, prospective, single-arm study being conducted at multiple sites in the U.S. Using an adaptive statistical design, the study enrolled 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat CLTI.
“The PROMISE II investigators are very encouraged by our experience using the LimFlow System to treat CLTI patients with no other options. These are likely the sickest patients ever to have been enrolled in a limb salvage trial,” said Daniel Clair, MD, PROMISE II principal investigator and Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “Major amputations have a devastating effect on the lives of patients and their families. We are excited about the prospect of helping improve the lives of more of these patients once this novel technology becomes broadly available.”
LimFlow also announced completion of enrollment in the CLariTI study of approximately 200 high-risk and no-option CLTI patients. The prospective, observational, multicenter CLariTI study will track the clinical progression of CLTI and incidence of death, amputation, and revascularization attempts in patients undergoing standard medical management for the disease over a one-year period.
“Despite suffering from the most advanced form of CLTI, these no-option and high risk patients have been excluded from other trials,” said Anahita Dua, MD, MS, MBA, FACS, CLariTI principal investigator, vascular surgeon at Massachusetts General Hospital, and Assistant Professor of Surgery at Harvard Medical School. “Our hope is that the CLariTI study gives us better insights into the reintervention, amputation and death rates in no-option and high-risk patients treated with the current standard of care.”
“It is tremendous to see the clinical community’s enthusiasm for the PROMISE II pivotal trial and the prospect of a new option for these desperate patients,” said LimFlow CEO Dan Rose. “While PROMISE II will demonstrate the progress of patients treated with LimFlow, CLariTI will tell us more about outcomes for high risk and no-option patients being treated with today’s interventional options. Running these studies concurrently gives us a wealth of data in order to learn about the progress of disease and quality of life in both treated and untreated patients. It will also highlight the gap between what is achievable with today’s FDA-approved therapies and what is possible with our transformational approach to CLTI using the LimFlow System.”
About Chronic Limb-Threatening Ischemia (CLTI)
CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and/or 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.
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About LimFlow and the LimFlow System
LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population.
When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, 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. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.