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AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.

AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline.

PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. PIVIT A/BTM ST is intended for single patient one-time use only.

PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference. PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents, rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.