Hotline 24/7: 0909384389

Share links:

LimFlow receives Japan PMDA approval for clinical study of minimally-invasive technology

Ngày 30/03/1988 12:22 | Lượt xem: 666

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 IIpivotal 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.

Source VascularNews

Duc Tin Clinic

Tin tức liên quan

Enrolment reaches midway point in trial of Early Bird bleed monitoring system

Eight-fold increased risk of heart attack seen in patients with subclinical obstructive coronary atherosclerosis

ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI

Blood pressure successfully cut in RADIANCE II ultrasound renal denervation trial

New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support