LimFlow announced today that it completed patient enrollment in the Promise II pivotal trial of its LimFlow system.
Paris-based LimFlow designed its LimFlow system to reestablish materialization in deep veins for chronic limb-threatening ischemia (CLTI) — a severe form of peripheral artery disease (PAD) — patients who have exhausted other methods and face major amputation of their lower limbs.
The multi-center, prospective, single-arm Promise II study across multiple U.S. sites enrolled 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing. Subjects will be followed out to three years.
LimFlow also completed enrollment in its CLariTI study of approximately 200 high-risk and no-option CLTI patients. That 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.
“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,” LimFlow CEO Dan Rose said in the release. “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.”