Japanese Regulators Approve Cardiovascular Surgical Patch

Osaka Medical and Pharmaceutical University, Fukui Tateami Co, Ltd., and Teijin Limited have received approval from Japan’s Ministry of Health, Labor and Welfare to market the SYNFOLIUM surgical patch. Teijin Medical Technologies Co. Ltd., a Teijin Group company, will manufacture and distribute SYNFOLIUM.

“We hope that SYNFOLIUM, which we developed as a strong industry-academia team, will help reduce the burden of re-operation for patients and their families,’’ Fukui Tateami President Yoshihide Takagi said. “As we Fukui Tateami celebrate our 80th anniversary next year, we are delighted to contribute to the future of children and to society as a whole through SYNFOLIUM.”
 
SYNFOLIUM is a surgical patch with knitted fabric consisting of both bio-absorbable and non-absorbable yarns coated with cross-linked gelatin. After the patch is surgically implanted into the body, patient’s tissue grows and gradually surrounds the expandable, non-absorbable portion while the bio-absorbable portion degrade. The regenerated tissue has a potential to reduce the risk of inflammatory reactions , foreign body reactions, and cell death, that often cause deterioration of the implants. To address this clinical problem, Shintaro Nemoto, M.D., Ph.D., of Osaka Medical and Pharmaceutical University, created an idea of a patch that could accommodate the growth of patients’ bodies by being restored by the patients’ own tissues. Fukui Tateami, a pioneer in warp-knitting technology, made Dr. Nemoto’s idea into a novel concept of an expandable cardiovascular patch that has a special knitted fabric structure to accommodate tissue regeneration and developed a prototype. Teijin, with experience in the healthcare sector through its pharmaceutical and home healthcare businesses, integrated the product design, development and regulatory works into the SYNFOLIUM patch. The three parties have been collaborating on development of this product since 2014.
 
This new product is to be used in the surgical treatment for patients with congenital heart disease (CHD). Neonates and infants with CHD generally undergo surgeries to correct hemodynamic problems due to septal defects or narrowed blood vessels (stenosis). Over a long period after surgery, a considerable number of them eventually require re-interventions, such as repeat surgery or catheter therapy.

“Many surgeons want to reduce repeat procedures as they cause heavy burdens on patients and their families,’’ stated Takayuki Nakano, Ph.D.,mission executive and general manager of Teijin Limited’s Regenerative Medicine & Implantable Medical Device Division. “We hope the SYNFOLIUM, an achievement of an industry-academiacollaboration with various stakeholders, will solve the issues of patients and their families and help improve their quality of life. In addition, as a manufacturer, we will work to expand the use of this surgical material from Japan to the world, and to develop further medical devices that make use of the concept of SYNFOLIUM.”
 
Japan’s Ministry of Health, Labor and Welfare designated the OFT-G1 as a “SAKIGAKE” device in April 2018, providing various incentives to accelerate its approval for clinical use. In clinical trials of CHD surgery conducted in Japan between 2019 to 2022, there occurred no reoperations and life-threatening events related to the patch. Based on these results, Teijin Medical Technologiessubmitted a marketing authorization application in Japan in January 2023.
 
Going forward, Osaka Medical and Pharmaceutical University, Fukui Tateami, Teijin and Teijin Medical Technologies will accelerate preparations for launching SYNFOLIUM in Japan. Theconsortium will continue to improve the current technology used for SYNFOLIUM, and will also expand the rproduct portfolio to improve the treatment and quality of life of patients with CHD in Japan and worldwide.
 
“The mission was very challenging, but our development team persevered with strong endurance. This significant milestone was achieved with incredible support from academic societies and regulatory authorities,’’ said Shintaro Nemoto, M.D., Ph.D., Department of Thoracic and Cardiovascular Surgery of Osaka Medical and Pharmaceutical University. “However, there are still challenges to overcome. We will continue to work together to complete the process of making SYNFOLIUM available to cardiac surgeons and their patients with CHD.”
 
The SYNFOLIUM name is derived from an English word “Syn” (together) and a Latin word “Folium” (leaf) with a wish that SYNFOLIUM would live along with the children who received surgeries, as a leaf.
 
Osaka Medical and Pharmaceutical University offers education and research in medicine, pharmacy, and nursing. Besides basic scientific research, its interdisciplinary research activities aim to solve unmet medical needs. Of note, various medical devices have been invented there by active industry-academia-government collaborations. The University Hospital provides various advanced medical treatments, such as cancer therapy including boron neutron capture therapy, robot surgery, and genomics medicine.
 
Fukui Tateami with 79 years of experience and advanced technology, has become one of Japan’s largest manufacturers of warp-knitted fabric with a wide spectrum of applications, including fashionwear, sportswear, automotive interiors, and industrial materials. After equipped with fully clean room in 2017, the company expanded its business field into the medical textiles to solve medical unmet needs. Fukui Tateami is the first textile company which obtained ISO13485 certification in Japan. Fukui Tateami posted sales of 3.1 billion yen ($20 million) and total assets of 2.6 billion yen ($17 million) in the fiscal year ending March 31, 2023.
 
Teijin is a technology-driven global group with two core businesses: high-performance materials and healthcare solutions. Established in 1918 as Japan’s first rayon manufacturer, Teijin today comprises some 170 companies employing 20,000 people in 20 countries. Teijin posted consolidated 1,018.8 billion yen in  sales ($7.6 billion) and total assets of 1,242.4 billion yen (9.2 billion) in the fiscal year ending March 31, 2023.