LimFlow SA has announced 24-month results from the PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, confirming “excellent and sustained outcomes” for both amputation-free survival and wound healing, a press release reports. The late-breaking data were presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).
“The presentation of the PROMISE I 24-month results validate the benefits of the LimFlow system,” said Daniel Clair, chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences in Nashville, USA, and PROMISE I principal investigator. “The high percentage of no-option CLTI [chronic limb-threatening ischaemia] patients that remained amputation free at 24-months is a major positive step forward for a condition characterised by high amputation and mortality rates.”
PROMISE I is a multicentre, prospective, single-arm study of the LimFlow system, conducted at seven study centres across the USA. All of the 32 patients enrolled in the study had non-healing wounds on the target foot. The primary endpoints were freedom from amputation, amputation-free survival, and survival overall. There were no amputations after day 75 in the study. At 24-months, freedom from amputation remained at 77% with an amputation-free survival of 59%. Three additional deaths within the second year of study resulted in 77% survival (two non-limb-related deaths; one from sepsis due to a non-healing wound in the non-treated foot). Ninety-two per cent had all wounds classified as healed or healing as adjudicated by an independent core lab. Technical success was reported at 97%.
“The two-year data from PROMISE I US feasibility study are highly encouraging and send a strong signal about the potential of the LimFlow system to strengthen our mission of no limb left behind,” said LimFlow CEO Dan Rose. “We are swiftly advancing our study of the LimFlow system in the ongoing PROMISE II US pivotal study in a patient population which is facing a very poor overall prognosis in terms of mortality and quality of life after major limb amputation. The LimFlow system is designed to help heal wounds and avoid major limb amputation, and we are proud of our mission of ‘No Limb Left Behind’.”