LimFlow has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow Percutaneous Deep Vein Arterialisation (pDVA) System.
PROMISE II is a multicentre, prospective, single-arm study to be conducted in the USA and Japan. Using an adaptive statistical design, the study plans to enrol 60 to 120 “no option” chronic limb-threatening ischaemia (CLTI) patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed 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.
The approval to initiate the pivotal trial follows completion of six-month follow-up of the US early feasibility study—PROMISE I—that successfully enrolled 32 patients at seven centres. Interim outcomes from the first 10 patients treated in the PROMISE I study showed nine patients surviving and amputation-free at one year, with seven of these patients experiencing complete wound healing. These results were presented in May at the New Cardiovascular Horizons Conference by Steve Henao, of the New Mexico Heart Institute. The complete results of PROMISE I will be presented during the Late Breaking Trials Session at the VIVA conference in Las Vegas in November.
“For these late-stage CLTI patients, success can be defined in two ways: wound healing and amputation-free survival. This exciting new therapy has the potential to restore blood flow to the ischaemic foot, which may help patients heal their wounds and keep their feet. I am very encouraged by the early experiences in the USA, and outcomes from this pivotal trial may offer hope to the many Americans who might otherwise face major amputations,” said 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.
“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,” said LimFlow CEO Dan Rose. “As part of the FDA Breakthrough Devices program, LimFlow is excited to commence its US 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.”
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, many of which are growing health problems. 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.