Synfolium Patch Offers Reduced Reoperation Risk
A revolutionary new medical patch, Synfolium, has been launched in Japan, offering hope for children with congenital heart disease. This innovative product, developed by Osaka Medical and Pharmaceutical University (OMPU), warp-knitted fabrics manufacturer Fukui Tateami Co., and textile giant Teijin Ltd., is designed to broaden blood vessels and reduce the need for repeat surgeries.
Congenital heart disease, affecting approximately 1 in 100 children, often requires surgery at a young age to widen blood vessels or restore blood flow. However, conventional surgical patches made from cow heart membranes or synthetic materials often deteriorate and fail to stretch as the child grows, leading to the need for reoperations.
one bioabsorbable and the other non-absorbable. This structure allows the patch to stretch more than twofold, accommodating the child's growth. Additionally, the patch is coated with a gelatin film that is replaced by the patient's own cells, forming new blood vessel walls within three months. The bioabsorbable yarns decompose in about two years, leaving behind a strong and flexible patch that grows with the child.
Clinical trials involving 34 patients in Japan have shown promising results. No serious complications or reoperations were reported after one year, and even after two years, only two patients required reinterventions. The Pharmaceuticals and Medical Devices Agency review report acknowledges the potential of Synfolium to reduce material deterioration and accommodate growth, but emphasizes the need for longer-term data.
Teijin plans to collect this data by studying the results of product use in 150 cases over five years. Additionally, they will pursue regulatory approvals in the United States, Europe, and other regions.
Professor Shintaro Nemoto of OMPU highlights the significance of this collaboration, stating that addressing the issue of reoperations was commercially unviable due to the small market size. He expresses gratitude to Fukui Tateami and Teijin for their commitment to the project and acknowledges the responsibility they bear in delivering long-term results.
The Synfolium patch represents a significant advancement in the treatment of congenital heart disease, offering hope for improved outcomes and reduced reoperations for children with this condition.