First CLTI patient enrolled in PROMISE II pivotal study of LimFlow system

LimFlow, a specialist in minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has announced that the first patient has been treated in its PROMISE II US pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.

The successful first case was performed by Mark Archie, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.

“We are pleased to be the first center in the country to treat a patient in this important trial,” said Archie. “The LimFlow System offers a promising new therapy with the potential to restore blood flow to the ischemic foot, heal wounds, and prevent major amputations in a patient population that today is unable to be treated with any current technology”.

PROMISE II is a multicentre, prospective, single-arm study being conducted in the USA and Japan. Using an adaptive statistical design, the study plans to enroll 60 to 120 “no option” CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed up out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.

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.

“Treating the first patient soon after FDA approval of the trial demonstrates the enthusiasm vascular specialists have for a therapy designed to help patients keep their limbs that would otherwise face amputation,” said LimFlow CEO Dan Rose. “With the increasing prevalence of diabetes, obesity and cardiovascular disease, CLTI has become a public health crisis, recognised by the FDA in designating the LimFlow system as a Breakthrough Device. We look forward to undertaking a rigorous study of our technology to offer new hope to patients who have no other options today.”

CLTI is the most severe form of PAD and often occurs in patients suffering from such conditions as 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.