Chronic Limb-Threatening Ischemia Treatment Study Okayed in Japan

LimFlow SA has won approval from the Japanese Pharmaceuticals and Medical Devices Agency to conduct its PROMISE II pivotal trial in the country. The ongoing study will determine the efficacy of its minimally invasive treatment for chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease.  

“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 ischemic 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, M.D., PROMISE II Japanese principal investigator and director, Cardiovascular Center, Fukuoka Sanno Hospital. “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.”

The PROMISE II pivotal trial is testing the efficacy of the company’s LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. The trial is a multi-center, prospective, single-arm study being conducted in the United States 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 enroll 60 to 120 “no option” 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.
 
Nobuyoshi Azuma, M.D., professor of Vascular Surgery at Asahikawa Medical University and a PROMISE II investigator said, “In Japan’s aging society, arteriosclerosis of the lower limbs is increasing, and severe lower limb ischemia 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.”

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. 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.
 
The pivotal PROMISE II clinical trial of the LimFlow System is currently enrolling patients at centers in the United States and Japan.
 
“We are excited about the momentum that adding several Japanese centers will bring to patient enrollment in our important PROMISE II trial,” said LimFlow CEO Dan Rose. “Participating in the HBD program allows us to leverage the clinical data from all patients enrolled in the U.S. and Japan towards Shonin approval in Japan. It also complements our acceptance in the FDA’s Breakthrough Device program, which is expected to accelerate our regulatory and reimbursement pathways. This is another promising step in our mission to bring our groundbreaking technology to CLTI patients who need it as soon as possible, wherever they may be in the world.”