Japanese Consortium Receives Approval for Innovative Surgical Patch, Synfolium, in Japan

In a groundbreaking development in the field of medical textiles, a consortium consisting of Osaka Medical and Pharmaceutical University, Fukui Tateami Co., Ltd., and Teijin Limited has obtained manufacturing and marketing approval in Japan for their revolutionary surgical patch, Synfolium. The patch, designed for the treatment of congenital heart disease (CHD), offers promising advancements in patient care and tissue regeneration.

Synfolium is a surgical patch composed of a knitted fabric that incorporates both bio-absorbable and non-absorbable yarns coated with cross-linked gelatin. When implanted into the patient’s body, the patch facilitates the growth of surrounding tissue while degrading the bio-absorbable portion. This innovative approach aims to reduce the risk of inflammatory reactions, foreign body reactions, and cell death, which commonly lead to implant deterioration.

The need for improved surgical solutions for patients with CHD is significant, particularly among neonates and infants who often require subsequent interventions due to the progression of the disease. Addressing this clinical challenge, Shintaro Nemoto of Osaka Medical and Pharmaceutical University conceptualized a patch that could adapt to the growth of patients’ bodies by restoring their own tissues. Fukui Tateami, known for its expertise in warp-knitting technology, transformed Nemoto’s idea into a prototype of an expandable cardiovascular patch with a unique knitted fabric structure to support tissue regeneration. Teijin, leveraging its experience in the healthcare sector, collaborated on product design, development, and regulatory processes to create the Synfolium patch.

Recognizing the potential of Synfolium, Japan’s Ministry of Health, Labour, and Welfare designated the patch as a ‘Sakigake’ device in 2018, providing incentives to accelerate its approval for clinical use. The consortium conducted clinical trials from 2019 to 2022, demonstrating positive outcomes with no reoperations or life-threatening events associated with the patch. Building on these successful results, Teijin Medical Technologies submitted a marketing authorization application in January 2023.

With the manufacturing and marketing approval secured, Osaka Medical and Pharmaceutical University, Fukui Tateami, Teijin, and Teijin Medical Technologies are now focused on expediting the launch of Synfolium in Japan to benefit patients as soon as possible. The consortium is committed to continuously improving the technology behind Synfolium while expanding its product portfolio to enhance the treatment and quality of life for patients with CHD both in Japan and worldwide.

The industry-academia collaboration that led to the development of Synfolium exemplifies the synergy achieved when academic institutions, medium and large-sized enterprises, and various stakeholders unite to address critical healthcare challenges. This achievement highlights the potential for significant growth in the Indian technical textiles industry if similar collaborations are fostered.

Synfolium’s approval marks a major milestone in the field of medical textiles and underscores the potential of advanced materials to revolutionize patient care. As Synfolium prepares to enter the market, it holds the promise of reducing the burden of repeat procedures for patients and their families, ultimately improving their quality of life. The consortium envisions expanding the use of this groundbreaking surgical material from Japan to the rest of the world and further developing medical devices based on the Synfolium concept.

The approval of Synfolium is not only a triumph for the consortium but also a significant leap forward in the treatment of congenital heart disease, offering hope to countless patients and their families worldwide.


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