Japan’s Teijin and its consortium partners Fukui Tateami, Osaka Medical and Pharmaceutical University plan to release Synfolium, a new cardiovascular surgical patch, in Japan.
Developed for the treatment of congenital heart disease (CHD), the patch is expected to be manufactured and distributed by Teijin Medical Technologies from 12 June 2024.
The Synfolium surgical patch combines bio-absorbable and non-absorbable yarns, coated with cross-linked gelatin.
Its design allows for the patient’s tissue to integrate with the patch, potentially reducing the risk of adverse reactions and improving the longevity of the implant.
Teijin developed the technology for coating knitted fabric with gelatin that is capable of preventing blood leakage. It can be replaced by the patient’s own tissue.
The company has been moving forward with design, development and clinical testing, as well as setting up a commercial production system and applying for manufacturing and marketing clearance in Japan.
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The collaborative development of Synfolium commenced in 2014 and has received support from the Ministry of Economy, Trade and Industry, as well as from the Japan Agency for Medical Research and Development (AMED).
The product was granted “Sakigake” designation by Japan’s Ministry of Health, Labor and Welfare in April 2018, expediting its clinical approval process.
Clinical trials for Synfolium commenced in 2019 and concluded in 2022.
Following successful trials, Teijin applied for and received manufacturing and sales approval in July 2023.
The consortium is now focused on disseminating clinical information to medical institutions and collecting data to confirm the product’s long-term safety and efficacy.
Looking beyond Japan, the consortium aims to introduce Synfolium to international markets, including the US and the EU, by obtaining the necessary approvals.
Additionally, the partners plan to leverage their experience to develop further medical solutions for CHD and other unmet medical needs.
