LimFlow SA announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.
PROMISE II is a multicentre, prospective, single-arm study being conducted in the USA and Japan as part of the Medical Device Harmonization by Doing (HBD) regulatory collaboration between the two countries.
Using an adaptive statistical design, the study plans to enrol 60–120 “no option” chronic limb-threatening ischaemia (CLTI) patients at 25 sites, four of which will be in Japan. The primary endpoint is amputation-free survival at six months; additional endpoints include limb salvage and wound healing. 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.
“Late-stage CLTI patients have a terrible quality of life, where they live with pain and limited mobility. Treatment success with these patients is defined by wound healing and amputation-free survival. The investigational LimFlow therapy has the potential to achieve both—by restoring oxygen-rich blood flow to the ischaemic foot, it may create the conditions for chronic wounds to heal, which may enable patients to avoid amputation and keep their limb,” said Hiroyoshi Yokoi (Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka, Japan), PROMISE II Japanese principal investigator. “We recently received Investigational Review Board approval to begin the PROMISE II trial at Fukuoka Sanno Hospital and I am enthusiastic about being able to offer a promising new option to my no-option patients.”
Nobuyoshi Azuma (Asahikawa Medical University, Asahikawa, Japan), a PROMISE II investigator said, “In Japan’s ageing society, arteriosclerosis of the lower limbs is increasing, and severe lower limb ischaemia encompassing foot pain, ulceration and necrosis due to impaired blood flow associated with diabetes and dialysis is becoming a major problem. We hope that pDVA with the LimFlow system will be a viable option and we look forward to starting the trial in Japan soon.”
The pivotal PROMISE II clinical trial of the LimFlow system is currently enrolling patients at centres in the USA and Japan.