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The consortium of Teijin Limited, Fukui Tateami Co., Ltd., and Osaka Medical and Pharmaceutical University announced that a novel surgical patch, under the brand name SYNFOLIUM®, will be released for manufacturing and distribution by Teijin Medical Technologies Co., Ltd. on June 12, 2024.

SYNFOLIUM® is a surgical patch with knitted fabric consisting of both bio-absorbable and non-absorbable yarns, which are coated with cross-linked gelatin. After the patch is surgically implanted in the body, the patient’s tissue grows and gradually surrounds the expandable, non-absorbable portion, while the bio-absorbable portion degrades. The regenerated tissue has the potential to reduce the risk of inflammatory reactions, foreign body reactions and cell death, which often cause deterioration of the implants.

This new product is designed to be used in surgical treatment of patients with congenital heart disease (CHD). The prevalence of CHD is 1 in 100 people globally, and in Japan, it is estimated that approximately 10,000 neonates are born with the disease each year. Newborns and infants with CHD generally undergo surgeries to correct hemodynamic problems due to septal defects or narrowed blood vessels (stenosis) by implanting a medical patch, usually made from synthetic or animal-derived materials. However, over a long period after surgery, a considerable number of patients eventually require re-interventions, such as repeat surgery or catheter therapy, due to the deterioration of the implanted patch. This deterioration can be caused by an immune-mediated foreign body reaction or the development of stenosis due to the inability of the patch to stretch in response to the growth of cardiac and vascular tissue.

To address this clinical problem, Shintaro Nemoto, M.D., Ph.D., of Osaka Medical and Pharmaceutical University, created an idea for a patch that could accommodate the growth of patients’ bodies through restoration by the patient’s own tissues. In 2012, he began research and exploration to make this idea a reality.

Fukui Tateami, a pioneer in warp-knitting technology based in Fukui Prefecture, turned Dr. Nemoto’s idea into the novel concept of an expandable cardiovascular patch. Based on advanced warp knitting technology it developed over the 80 years since its founding, the company created a special knitted fabric structure to accommodate tissue regeneration.

Teijin developed the technology to coat knitted fabric with gelatin, which can prevent blood leakage and can be replaced by the patient’s own tissue. The company has been proceeding with design and development, clinical trials, establishment of a commercial production system, and application for manufacturing and marketing approval in Japan.

The development of SYNFOLIUM® has been supported by the Ministry of Economy, Trade and Industry since 2014, as well as by a program launched in 2017 by the Japan Agency for Medical Research and Development (AMED) to facilitate collaboration between medical academia and industry. Japan’s Ministry of Health, Labor and Welfare designated SYNFOLIUM® as a “SAKIGAKE” device in April 2018, providing various incentives to speed up approval for clinical use. In addition, the Japanese Society of Pediatric Cardiology and Cardiac Surgery cooperated by assisting with clinical trials and providing advice on creating guidelines for appropriate use.

Clinical trials that began in 2019 were completed in 2022, and Teijin Medical Technologies applied for manufacturing and sales approval to the Ministry of Health, Labor and Welfare in January 2023. The company received approval in July of the same year.

Going forward, Teijin and Teijin Medical Technologies, Fukui Tateami, and Osaka Medical and Pharmaceutical University will provide clinical information about this product to medical institutions to facilitate its use in patients with CHD. Teijin and Teijin Medical Technologies will continue to collect and analyze cases using SYNFOLIUM® to establish its long-term safety and efficacy.

Furthermore, to help improve the quality of life of patients with CHD around the world, the consortium plans to market SYNFOLIUM® overseas by working to gain manufacturing and marketing approval in the United States, the European Union and other countries.