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The Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The Bard The PerFix™ Light Plug is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

The Proposed Product, Bard® PERFIX™ Light Plug is a pre-formed three-dimensional (cone shape) device constructed of a fluted outer layer and multiple inner layers of mesh attached at the tip. The device has a large pore design and is constructed of knitted polypropylene monofilaments. The pores in the mesh allow for tissue ingrowth. A separate flat, pre-shaped onlay patch (2.3" x 5.4") will be packaged with each device. The Bard® PERFIX™ Light Plug will be offered in a range of sizes with the largest being the extra large PerFix™ Plug 1.5" x 2.0" (4.1cm x 5.0cm). The extra large size consists of three (3) preformed medium shells held in place, side by side, inside a pre-formed large shell. The small, medium and large sizes consist of an outer cone with 2 pieces of mesh (petals) to help the plug maintain its fluted form. The inner petals and cones are sewn together at the tip with a single polypropylene monofilament thread.

The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.

The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

Bard Composix L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The Composix® L/P Mesh, will consist of a layer of polypropylene mesh and a layer of expanded polytetrafloroethylene (ePTFE) stitched together using Polytetrafluroethylene (PTFE) monofilament thread sewn in a lock stitch formation. The polypropylene layer is knitted from 0.0048 inch polypropylene monofilament, which is identical to the currently marketed Large Pore Soft™ Mesh. The thickness of the ePTFE layer is identical to the currently marketed Composix® E/X Mesh. As with the currently marketed Composix E/X, the peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer. The layers of the Composix L/P Mesh will be sewn together using rows of interspaced stitching, which will allow the surgeon to tailor the product. Using the stitch pattern as a guide, the surgeon can tailor the product. For user convenience to facilitate the deployment of the larger sized Composix L/P products, the larger sizes of the Composix L/P products will be packaged with an Introducer Tool. This Introducer Tool is similar to the rolling tines/plunger assembly and T-handle of the PrecisionPass™ Delivery Device. The Introducer Tool consists of a handle with a thin stainless steel rod. The stainless steel rod is split into two pieces along its length and has ridges around the perimeter to facilitate use. Similar to the T-handle provided with the PrecisionPass Device, the Introducer Tool's T-cap will be used to secure the open end of the metal rolling tines during the rolling process, then removed prior to delivering the device through the trocar.

Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.

The Salute® II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

The Salute II Disposable Fixation Device consists of a handle, shaft/shaft tip and comes preloaded with 316L stainless steel wire. The device is used to deliver permanently implanted Q-shaped constructs (Q-Rings). Depending on user preference, the device is offered in an 18cm shaft preloaded with either 10 or 30 Q-Rings and a 38cm shaft (fits into a 5mm trocar) preloaded with either 10, 30, or 60 Q-Rings.

The Salute® Fixation System is indicated for use in a variety of laparoscopic/ endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

The Salute Fixation System consists of a reusable handle, shaft and shaft tip, as well as a sterile, disposable implant cartridge with wire survey ube and cover. The disposable implant cartridge comes prektades from 316L stainless steel wire. The device is used to deliver permanently maginn on Q-shaped rings (Q-ring). Depending on user preference, the handle may be used with an 18cm shaft or a 38cm shaft (fits into a 5mm trocal). Implant cartridges are offered with sufficient 316L stainless steel wire to form 10, 20, 30, or 50 Q-rings and are designed to work with either a 38cm shaft or an 18cm shaft. The handle and shaft are engraved with serial numbers, which must match in order for the device to function properly. The Instructions for Use (IFU) contain information to insure the implant cartridge is used with an appropriate shaft and to confir:: serial numbers of the shaft/handle match.