Therapy Areas: Devices
ACell wins additional clearances from US FDA for Gentrix Surgical Matrix hernia portfolio
4 April 2019 -

Medicine company ACell Inc revealed on Wednesday the receipt of new 510(k) clearance from the US Food and Drug Administration (FDA) for several devices for complex hernia repair under its Gentrix Surgical Matrix suite of products.

This clearance expands the specific indications to add new claims to the product labelling in Gentrix Surgical Matrix, Gentrix Surgical Matrix Thin and Gentrix Surgical Matrix Plus. The devices were shown to minimise unwanted attachment to surrounding visceral tissue and ACell gained specific indication for use of these three Gentrix devices in laparoscopic applications. It also obtained clearance for a new hernia device configuration specifically indicated for reinforcement of hiatal hernia repairs.

On 3-6 April 2018, the pre-clinical data used to support the new clearances will be presented in two posters at the Society of American Gastrointestinal and Endoscopic Surgeons Annual Meeting in Baltimore, Maryland.

The company's Gentrix Surgical Matrix Thin (three layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Gentrix Surgical Matrix and Gentri Surgical Matrix Plus (six layer and eight layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery.

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