After a period of consultation with its notified body Tissuemed has confirmed several changes to the wording used to describe the indications for use of its TissuePatch products. David Mandley, Tissuemed’s director responsible for Regulatory Affairs, who has driven the changes stated that; “These changes are subtle but meaningful and while they do not extend the number of procedures for which the product can be used, they do make it clear that the products can be used on most soft tissues and in the case of TissuePatchDural that the product functions to reinforce Dura and in so doing prevent CSF and/or blood leakage”
The indications statements for the two products now read as follows:
TissuePatch3 is indicated for use to seal and reinforce against air leakage in thoracic surgery and against leakage of low pressure or oozing bleeding or fluid leakage following surgical procedures on soft tissue. TissuePatch3 is intended for use as an adjunct and is not intended to replace sutures or staples, as appropriate, in tissue approximation.
TissuePatchDural is indicated for use to seal and reinforce against fluid (including cerebrospinal fluid (CSF)) and/or blood leakage where repair of the dura mater is required. TissuePatchDural is intended for use as an adjunct. It is not intended to replace sutures, staples or clips, as appropriate, in tissue approximation. Furthermore it is not intended to be used as a dura mater substitute.