Bioshield Pocket XL Size
Starting from Q3 2021, the fourth size of the Bovine Pericardium Bilayer Bioshield Pocket Membrane will be available.
This is a huge step forward for the Exashape line because it fills the gap towards the Competitors that produce their own matrices from the animal dermis.
In fact, the animal dermis – despite being a lower value source (due to its biological, mechanical properties and its excessive thickness) – is widely used because of its abundant availability in nature and its dimensions that are not comparable to the pericardium ones. This allows to produce membranes both in considerable quantities and – above all – in different formats.
This innovation — in the case of mesh for the prepackaging of prostheses in the prepectoral implantation technique – allows to create devices able to cover even the models of large-sized prostheses; while – until yesterday – pericardial membranes were generally considered suitable to assembly with prostheses until a 550 cc maximum volume.
The ASSUT Europe’s R&D department has completed an extraordinary work that has made possible the creation of the Bioshield Pocket XL membrane with a surface of 460 cm² (23 x 20 cm), able to cover prostheses with a volume of 650 cc and more, perfectly.
This underlines the first-rate level of the industrial structure of the ASSUT manufacturer, thanks to the numerous teams of professionals — perfectly coordinated — experts in their specific fields.
Nevertheless, the new format, on the one hand, fills the gap to the Competitors that offer dermis-based membranes, but, on the other hand, it defines a competitive advantage – setting a new standard – that is difficult to fill for all manufacturers of pericardium meshes.
These meshes – due to limits dictated by the maximum age of the cattle that can be selected within the single protocol, and also to restrictions determined by the technical file established in agreement with the Notifier Body by each manufacturer – do not reach the formats of Bioshield Pocket XL, and therefore remain excluded from a market subsegment of considerable importance.
In fact, the absence of an XL size does not allow the Surgeons to adopt a standardization of this surgical procedure, forcing them to use a device made of a certain origin for patients of medium-small size (eg: pericardium) and another, (dermis) for large-sized patients.
This, if we don’t want to consider also the obstacle posed by all the Tender Specifications in which the availability of four sizes or membranes for breast reconstruction with a size equal to or greater than 450 cm² was requested, which would exclude – by default –all Manufactures that fail to comply with the required requirements.