Medical device firm LimFlow has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) pivotal study of its Percutaneous Deep Vein Arterialization (pDVA) System.
The pDVA device is meant for minimally invasive prevention of amputations in chronic limb-threatening ischemia patients who did not have an adequate response to all other therapeutic interventions.
It is developed to bypass blocked arteries in the leg and deliver oxygenated blood through the veins into the foot. The restoration of perfusion in the lower limbs is expected to alleviate chronic pain, allow wound healing, prevent major amputation and improve quality of life.
The multi-centre, prospective, single-arm IDE study, called PROMISE II, will be conducted in around 60 to 120 CLTI patients who have exhausted all other options.
To be performed in the US and Japan, the study will track amputation-free survival at six months, limb salvage and wound healing. It involves a follow-up of three years.
LimFlow has previously conducted a US Early Feasibility Study (PROMISE I) in 32 patients at seven sites with a six-month follow-up.
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Interim data showed that out of the initial ten patients treated with the pDVA System, nine patients were amputation-free at one year and seven of these patients achieved complete wound healing.
LimFlow CEO Dan Rose said: “Major amputations have a devastating effect on the lives of patients and their families, and each one is a personal tragedy. Chronic limb-threatening ischemia is a public health crisis and far too many limb amputations are performed in the world today, costing the healthcare system many billions of dollars.
“As part of the FDA Breakthrough Devices programme, LimFlow is excited to commence its U.S. pivotal trial on the heels of the successful experience from the US feasibility study. This is a tremendous milestone that furthers our mission of empowering vascular specialists to offer new hope to their CLTI patients who may be only days away from losing a limb.”