Congenital Heart Disease (CHD) is a condition that can affect structure of heart, such as narrowed blood vessels (stenosis) and septal defects, resulting in cardiac abnormalities. In the treatment for patients with CHD, surgeries using surgical patches are performed to correct hemodynamic problems due to septal defects or stenosis, and most of patients undergoing such surgeries are neonates or infants. As they grow, the implanted patch may deteriorate due to foreign body reactions or fail to follow the growth of patients' bodies, leading to stenosis in the surgical area and requiring reoperations. To address these concerns, we have developed "a patch that can accommodate patients' growth by being replaced with their own tissues", based on the idea of Shintaro Nemoto, M.D., Ph.D., of Osaka Medical and Pharmaceutical University.

This product is a soft patch with knitted fabric consisting of both bio-absorbable and non-absorbable yarns coated with cross-linked gelatin. After surgically implanted, its gelatin degrades followed by the gradual degradation of the absorbable yarns, allowing the patient's autologous tissue to infiltrate through the product.
The unique knitted structure of this product, developed by Fukui Tateami Co., Ltd., has the strength enough to withstand suture and blood pressure. Once implanted and absorbable yarns degraded, the remaining non-absorbable yarns is designed to accommodate the growth by expanding its structure.
The cross-linked gelatin used in this product prevents the leakage of blood and is covered by autologous tissue. Its unique blending amount, blending method, and process of cross-linking etc enable such performances. In the animal study, it exhibits high affinity with cells and gradually degrades by enzymes during the process of tissue restoration, without excessive inflammatory reactions or hypertrophy, resulting in the structure similar to blood vessel tissue. This property of tissue restoration is expected to reduce the common issues such as foreign body reactions and calcification.

This product has been developed by the synergy of medical expertise and idea of Professor Nemoto, unique knitting technology by Fukui Tateami Co., Ltd, and technologies in material and healthcare expertise of Teijin. The development of this product had been supported by a special program designed to facilitate collaborations between medical academia and industrial field promoted by AMED, the Japan Agency for Medical Research and Development. Furthermore, it was designated as a "SAKIGAKE" device under the pioneering drug and medical device designation system. This successful development project is an important innovation achieved by strong collaboration among industry, academia, and government.

Currently, this cardiovascular surgical patch is available only in Japan. We plan to expand its launch and use in worldwide. Furthermore, we will utilize the technology and knowledge gained from this development to advance research and development of implantable medical devices focusing on not only cardiovascular surgery but also other applications.