LimFlow SA has announced the presentation of one-year data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, showing sustained positive outcomes for both amputation-free survival and complete wound healing. Results were presented in the a late-breaking data session at this year’s Vascular Interventional Advances meeting (VIVA 2020; 6–8 November, virtual) conference by Daniel Clair (University of South Carolina [USC] and Prisma Health-USC Medical Group, Columbia, USA).
The one-year results from the PROMISE I study show that 70% of patients achieved major amputation-free survival, similar to what was seen at six months, following treatment with the LimFlow system. The patients in the trial also had 75% of their wounds classified as healed or healing one year after treatment. Technical success was reported at 97%.
“One-year outcomes demonstrate that the benefits from treatment with the LimFlow system are durable,” said Clair. “One of the greatest challenges in the treatment of CLTI [chronic limb-threatening ischaemia] 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 multicentre, prospective, single-arm study of the LimFlow system conducted at seven US centres encompassing 32 end-stage—or “no option”—CLTI patients, 100% of whom had non-healing wounds on the target foot, 69% of whom had diabetes and 34% 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.
The pivotal PROMISE II clinical trial of the LimFlow system is currently enrolling patients at centres across the USA.