The recent news that Pleuraseal has been withdrawn from the market has provoked surgical sealant manufacturer Tissuemed to ramp inventory levels of its recently launched TissuePatchThoracic product. Covidien has informed its customers of the product’s withdrawal in writing. This seems to be related to results from its US FDA clinical study which have not provided clear evidence of a comparative advantage when using Pleuraseal compared with controls.
Tissuemed has commented that “Use of sealants to resolve or prevent air leaks in lung surgery is a subject that provokes divided opinions, mainly because so many generic offerings have been tried over the years. Surgeons are looking for a quick and effective solution to a challenging problem, and some form of liquid sealant seems intuitively like a good idea. We believe our purpose-designed technology to be superior however, it being an adhesive film that covalently bonds to the tissue surface with a force greater than can be achieved with polymerising liquids*. The evidence is good and building that the use of TissuePatch technology facilitates earlier air leak resolution, drain removal and potentially patient discharge. The good news for surgeons keen to try another air leak reduction tool is that the product is quick and easy to use, requires no preparation and is functionally effective within seconds.”
Tissuemed’s new foray into the lung sealant market is enhanced with the introduction of its VATS delivery capability in which TissuePatch can now be dispensed directly onto the surgical site using dedicated instrumentation.
Tissuemed is responding to increasing demand by adding further production batches to its schedule.
*data on file