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Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness involving soft tissue repair, such as for the repair of hernias. The Echo 2™ Positioning System is intended to facilitate the delivery and positioning of the mest during laparoscopic hernia repair.

The Phasix™ ST Mesh with Echo 2™ Positioning System is a sterile single use mesh preattached to the Echo 2™ Positioning System. The subject device is a combination of the FDA cleared Phasix™ ST Mesh (K173143) and the Echo 2™ Positioning System that is cleared by the FDA in the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294). The Echo 2™ Positioning System is removed following the mesh placement and fixation. As with the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294), many sizes of the subject device include an introducer tool accessory. The subject device is intended for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias and will utilize a positioning system to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair. Procedures involving "laparoscopic hernia repair" also pertain to those which are conducted under laparoscopic visualization through a trocar, such as robotic assisted laparoscopic ventral hernia repair (LVHR). The Phasix™ ST Mesh in the subject device is a fully resorbable mesh with a resorbable hydrogel coating and is identical to the secondary predicate device, Phasix™ ST Mesh (K173143). It is co-knitted using Poly-4-hydroxybutyrate (P4HB) and Polyglycolic Acid (PGA) fibers to form two sided mesh. The PGA side of the mesh is coated with a bioresorbable, chemically modified sodium hyaluronate (HA), Carboxymethylcellulose (CMC) and Polyethylene Glycol (PEG) based hydrogel. The fascial P4HB side of the mesh allows for a prompt fibroblastic response through its interstices, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral PGA side of the mesh coated with a bioresorbable hydrogel separates the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers is observed in preclinical studies within 12 to 18 months, indicating loss in mechanical integrity and strength of the mesh. While fiber segments were observed at 18 months, they continued to degrade. This Phasix™ ST Mesh (K173143) is preattached to the Echo 2™ positioning system on the hydrogel side of the mesh using nylon connectors. The Echo 2™ Positioning System is composed of nitinol wire, encased in a sealed nylon frame. A Polyethylene Terephthalate (PET) center hoisting suture is attached to the nylon frame. The Echo 2™ positioning system utilized in the subject device is identical in materials and construction to the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294).Once inserted into the abdomen, the positioning system facilitates both deployment and positioning of the mesh. After initial fixation is complete, the Echo 2™ Positioning System is manually detached from the mesh and then removed from the body through a trocar or skin incision.

The CapSure ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The CAPSURE™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.