A joint development agreement for an abdominal aortic aneurysm stent graft has been concluded among Dr. Takao Ohki, Chairman of the Department of Surgery, Professor and Chief of the Department of Vascular Surgery, Jikei University School of Medicine; MANI Inc.; Asahi Kasei Corp.; Kawasumi Laboratories, Inc.; and the Japanese Organization for Medical Device Development, Inc. (JOMDD).
The product under development would be Japan’s first stent graft for abdominal aortic aneurysm. Featuring smaller diameter than currently available stent grafts, it is designed to enable minimally invasive treatment with greater safety which will allow the procedure to be provided to a wider range of patients. Development is advancing with an aim of obtaining regulatory approval in Japan, the US, and Europe at the same time.
The five parties to the agreement are targeting completion of non-clinical studies by 2020. Prof. Ohki is serving as medical advisor, Asahi Kasei and MANI are providing material know-how, and Kawasumi Laboratories is providing manufacturing and sales experience, with the support of JOMDD.
About treatment of abdominal aortic aneurysm and features of the product under development
Abdominal aortic aneurysm is currently treated either by surgery in which the abdomen is opened to cut out diseased section of aorta and replace it with a synthetic graft, or by a procedure to place a stent graft inside of the diseased aorta and making a new path for blood flow. Having a smaller-diameter delivery sheath (catheter) than is currently available, it is believed that the new product will enable the minimally invasive procedure of percutaneous insertion of a stent graft to be applied to a wider range of patients, reducing the need for open surgery using general anesthesia.