FDA Approves Duo of Hernia Repair Products

SEPTEMBER 13, 2019
Kenny Walter
The US Food and Drug Administration (FDA) has approved 2 different mesh devices aimed at repairing hernias.

Both the Phasix ST Mesh with Open Positioning System and the OptiFix AT Absorbable Fixation System with Articulating Technology will join a long-list of hernia repair products produced by BD.

Phasix ST Mesh with Open Positioning System is the only approved pocketed bioresorbable mesh with a removable positing system aimed at streamlining intraabdominal mesh placement in open complex abdominal wall repair.

Bioresorbable mesh is intended to reinforce soft tissue where a weakness exists. For example, using Phasix allows the abdominal wall to be repaired without the need for a permanent implant because the mesh works with the body to rebuild the tissue and gradually and predictably remodel to help leave a strong repair.

In preclinical studies, investigators found the overall procedure time is 43% faster with twice the strength when compared to conventional mesh devices. So far, more than 25,000 repairs have been made using the Phasix ST Mesh, which has a clinically-proven hydrogel barrier that minimizes tissue attachment.

The new Open Positioning System helps create consistent repairs with easier mesh insertion, accurate centering, better conformance to the abdominal wall, and easier fixation.   

OptiFix AT Absorbable Fixation System with Articulating Technology is the only preloaded articulating mesh fixation device that accommodates many types of surgical techniques in hernia repair, including open or minimally invasive hernia repairs.

The device does not have cartridges, but is preloaded with 15 or 30 fasteners to create less disruption, while helping to improve procedural efficiency. The fasteners include a hollow core that allows tissue ingrowth through the fastener.

OptiFix AT Absorbable Fixation System with Articulating Technology also facilitates mesh positioning and reduces the chance for the mesh to be pulled away during the procedure.

The device also includes a rotating handle with an articulating tip to enable surgeons to easily access mesh from 1 side of the patient to reduce total number of trocars needed. Past research suggest that reducing trocars could result in cost savings and a reduced risk of infection and trocar site herniation.

Optifix AT Absorbable Fixation System with Articulating Technology can also be used fully straight or it can be articulated to better access difficult to fixate areas.

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