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The Sientra AlloX2 Pro Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities. Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not teplace short-term, immediate, intraoperatively placed drains.

The Sientra AlloX2 Pro Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a smooth surface and an integrated magnetically locatable port system for incremental expander filling. The Sientra AlloX2 Pro Tissue Expanders have an incorporated drainage system accessed by a drain port. The incorporated drain system allows for aspiration of fluids from the periprosthetic space that may present during the expansion process. Both the integrated fill and drain ports can be accessed with an 18- gauge needle or smaller. The AlloX2 Pro Tissue Expanders have suture tabs providing an option for surgeons to suture the expander within the breast pocket. The AlloX2 Pro Tissue Expanders are labeled Magnetic Resonance (MR) Conditional. Patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions. The potential resulting risks associated with using the device in the MRI environment include the inability to fill the device, loss of port location functionality and potential reoperation should the patient require continued function of the tissue expander device after MRI exposure. The Sientra AlloX2 Pro Tissue Expanders are manufactured in both mid-height and fullheight base options from 11 cm to 16 cm to meet diverse patient needs and to achieve individualized aesthetic results. The Sientra AlloX2 Pro Tissue Expanders are supplied sterile. The Sientra AlloX2 Pro Tissue Expander accessories include a magnetic port locating device (PRO Locator) that allows for simultaneous identification of the fill and drain ports for ease of identification, and a 21-gauge winged needle infusion set. Both are supplied sterile and individually packaged inside the product box.

The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders. The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system. The enclosed device is nonsterile and for postoperative use only.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander. The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes. The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location. The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.