Japan Approves PROMISE II Trial to Evaluate LimFlow’s pDVA System for CLTI

March 23, 2021—LimFlow SA announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company’s Clinical Trial Notification for the Japanese cohort of the ongoing pivotal PROMISE II trial of the LimFlow percutaneous deep vein arterialization (pDVA) system for the treatment of chronic limb-threatening ischemia (CLTI).

According to the company, PROMISE II is a multicenter, prospective, single-arm study being conducted in the United States and Japan as part of the Medical Device Harmonization by Doing 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 company explained that 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 primary endpoint is amputation-free survival at 6 months; additional endpoints include limb salvage and wound healing. Patients in the study will be followed out to 3 years.

Hiroyoshi Yokoi, MD, who is Director, Cardiovascular Center, Fukuoka Sanno Hospital in Fukuoka, Japan, serves as the PROMISE II Japanese principal investigator.

“Late-stage CLTI patients have a terrible quality of life, where they live with pain and limited mobility,” commented Dr. Yokoi in the company’s press release. “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.”

Dr. Yokoi continued, “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.”

PROMISE II investigator Nobuyoshi Azuma, MD, added, “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.” Dr. Azuma is Professor of Vascular Surgery at Asahikawa Medical University in Asahikawa, Japan.

The company advised that the LimFlow system has not been approved for sale in the United States, Canada, or Japan. It received CE Mark approval in October 2016 and is available commercially in Europe.