Topics & News Release
Toyo Advanced Technologies Acquires Medical Device Manufacturing Permit for Coronary Artery Stents,
- We are the first in Japan to get manufacturing permits for both stent processing and DLC coating. -
Toyo Advanced Technologies Co., Ltd. (Head office: Minami-ku, Hiroshima City, President: Yoshiaki Hongo) has acquired a medical device manufacturing permit for coronary artery stents. Our company already has acquired ISO13485, a quality management system standard for medical tools and design/manufacturing, and we have established a production system, test-producing coronary artery stents. By acquiring the manufacturing permit required by the Pharmaceutical Affairs Act, we can now begin full-scale provision to medical device manufacturers and dealers.
A coronary artery stent is a metal mesh tube and an advanced medical device used to treat clots in the coronary artery of the heart caused by cholesterol or blood clots. Doctors use a catheter to insert the stent into the affected area, widening the narrow blood vessel and keeping it in place, thus ensuring blood flow. We do not only process the materials into stent form, but if necessary, also coat the stent's surface with DLC (Diamond-like Carbon), a hard carbon film.
DLC is primarily made of carbon, which is highly compatible with organisms, and therefore is characterized by low-invasiveness even when used inside the body. However, because the stent needs to expand within the blood vessel, the DLC would peel easily and it was difficult to make the stent perform sufficiently. We developed a new DLC with increased tenacity, characterized by its ability to achieve DLC coating that does not peel easily. We carry out the stent processing at our head plant (Hiroshima Prefecture) and the DLC coating at our Tokyo plant (Saitama Prefecture), and we acquired this manufacturing permit at both locations. We are the first company in Japan to acquire medical device manufacturing permits for both stent processing and DLC coating.
In 2008, the Cabinet of the Japanese government decided on the "Basic Policy for Economic and Financial Reform 2008". To promote the development of revolutionary technology as a strategy for economic growth, the government established "Special Zones for Revolutionary Technology (Super Zones)", which hold parallel discussions with departments that handle exceptions for research funding or regulations, on a trial basis. As that first step, the "Special Zone for Advanced Medical Development", a joint operation of four ministries (the Cabinet Office, the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry) was established, advancing development of cutting-edge regenerative medicine, drugs, and medical devices.
Toyo Advanced Technology participates in a research group with the theme, "interdisciplinary and comprehensive research related to the development, clinical application, and commercialization of advanced medical devices related to the circulatory system", one of the development fields for revolutionary medical devices in the Special Zone. In the same field, we aim to create "revolutionary catheter medical devices for circulatory diseases", which play an important role in minimally invasive treatments, including the coronary artery stent. We are advancing our research to achieve commercialization in the areas of microfabrication for stents and DLC surface processing technology.