Minimally invasive technology developer LimFlow has reported positive data from the PROMISE II US pivotal trial of its LimFlow System.
The single-arm, multi-centre, prospective trial included 105 no-option chronic limb-threatening ischemia (CLTI) patients, who were treated at 20 sites across the US.
According to the findings, published in the New England Journal of Medicine (NEJM), the LimFlow System achieved 66% amputation-free survival, where patients were alive and amputation-free, at six months.
It also showed that 76% of patients had wounds that were completely healed (25%) or in the process of healing (51%).
Furthermore, there was a substantial reduction in patient pain, and the average pain scores dropped to 3.0/10 six months after treatment, from 5.3/10 before treatment.
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The trial also showed a 76% limb salvage rate, where over three-quarters of participants kept their leg and avoided amputation.
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By GlobalDataLimFlow CEO Dan Rose said: “Too often, patients are confronted with the limits of traditional interventional options and must undergo a major amputation, which often leads to severe complications, greatly reduced quality of life, and an early death.
“The LimFlow System demonstrated remarkable success in relieving patients’ pain and healing their wounds, diverting them from amputation and putting them on a path towards a better life.”
The LimFlow System has been designed to re-establish blood flow in deep veins during transcatheter arterialisation of deep veins (TADV) for no-option CLTI patients who have exhausted all other treatment procedures and face major amputation of their lower limbs.
It is intended to prevent amputation, which is associated with significant complications, deterioration of quality of life and mortality.
The company stated that the findings from the PROMISE II trial exceeded the performance goals of the US Food and Drug Administration (FDA) with statistical significance.
