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510(k) Clearance Received for Endoform® Plastics and Reconstructive Matrix20 Dec 2016

Aroa Biosurgery has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s Endoform® Plastics and Reconstructive Matrix, which allows the company to market and sell this device in the USA.

The Endoform Plastics and Reconstructive Matrix is an advanced extracellular matrix device for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

This device is built using Aroa Biosurgery’s proprietary Endoform platform derived from ovine forestomach matrix. Endoform is a building block that serves as the underlying architecture for a wide range of medical devices. Read more about the Endoform platform here.

The Endoform Plastics and Reconstructive Matrix is laminated using Aroa Biosurgery’s new proprietary process termed ‘lug lamination’, where the multiple layers are physically bonded to one another rather than using sutures.  This process eliminates the need to introduce additional polymers and increases fluid permeability. The device is supplied sterile and dry in a variety of sizes and thicknesses.

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