Tissuemed Ltd (Leeds, UK) has been granted regulatory approval of its TissuePatch™ range of ultra-thin surgical sealant films by the Chinese FDA (CFDA).
TissuePatch™ is the first and only synthetic sealant to be approved by the CFDA, giving Tissuemed sole access to a significant medical device market that is being driven by both an increase in income and a population greater than 1 billion, ageing faster than any other country. Sales of medical devices in China have increased rapidly over the last decade, exceeding £30 billion in 2015.
The approval comes at the end of an exhaustive two and a half year programme and importantly covers all surgical applications for TissuePatch sealant film technology, allowing Tissuemed to extend its product reach beyond the traditional Neuro and Thoracic spaces.
Through Tissuemed’s carefully chosen distributor, Chinese surgeons will now be able to use the company’s unique products to prevent leaks after surgery, reducing post-operative complications and the need for extended hospital stay.