LimFlow SA today announced the presentation of positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the LimFlow percutaneous deep vein arterialisation system. Results were presented on the podium at the 2019 Vascular InterVentional Advances conference (VIVA; 4–7 November, Las Vegas, USA) by Daniel Clair, PROMISE II principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Palmetto Health-USC Medical Group.
“Findings from this early feasibility trial are very promising,” said Clair. “They show that the LimFlow system is a novel, safe and reproducible approach for improving wound healing and reducing amputation rates in a patient population for whom amputation would otherwise be considered inevitable. It is very encouraging to be able to offer hope to patients that cannot be treated with any current technology today.”
PROMISE I is a multicentre, prospective, single-arm study 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.
At six months, the LimFlow system achieved an amputation-free survival rate of 74%. A strong trend of successful wound healing was also demonstrated, with 67% of wounds classified as healed or healing at six months and 100 percent healed or healing at nine months. Technical success was 97%.
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.
“We are enthusiastic about the exceptional results for the LimFlow System,” said LimFlow CEO Dan Rose. “Our goal with the technology is to fully heal previously non-healing wounds and save more patients from amputation, improving their quality of life and preventing the downward spiral that comes from losing a limb. With the recent FDA approval of our pivotal trial, we look forward to shortly commencing enrolment in the USA and continuing to build evidence for the therapy.”
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.