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The AeroForm® Tissue Expander System, Smooth is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts and for the treatment of soft tissue deformities in the breast. The AeroForm® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months

The AeroForm Tissue Expander System, Smooth is a sterile, temporary implant for breast reconstruction. This device is comprised of an implantable tissue expander (Expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander, Smooth is constructed of an outer silicone shell and an inner gas barrier (bag) with an internal reservoir of compressed Carbon Dioxide (CO2) gas. The CO2 gas is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, two-stage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.

The AeroForm® Tissue Expander System is used for soft tissue expansion in breast reconstruction following mastectorny. for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast. The AeroForm® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond 6 months.

The AeroForm Tissue Expander System (AeroForm System) is a sterile temporary implant for breast reconstruction and is comprised of a sterile, implantable tissue expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander is a comprised of an outer textured silicone shell, an inner gas barrier (bag), with an internal reservoir of compressed Carbon Dioxide (CO2) gas, which is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, twostage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.

The AeroForm Tissue Expander System is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast. The AeroForm Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The AeroForm® Tissue Expander System is comprised of the AeroForm Tissue Expander, the Dosage Controller, and the Physician Master Key. The AeroForm Tissue Expander is a sterile implant with an outer textured silicone shell and a non-distensible inner bag which are anatomically shaped to allow for directional expansion in the lower, anterior pole. The AeroForm Tissue Expander contains a reservoir of compressed carbon dioxide (CO2), which is released within the AeroForm Tissue Expander by using the Dosage Controller. The outer shell has suture tabs to allow fixation of the device to the surrounding tissues to prevent rotation. A receiving antenna and electronics within the AeroForm Tissue Expander enable communication with the Dosage Controller. The AeroForm Tissue Expander has no intrinsic electrical power, batteries, or software, and can only be activated by the Dosage Controller. There are 3 different sizes of the expander, including small (400cc), medium (600cc), and large (850cc). The Dosage Controller is a small, hand held battery-powered, non-sterile device. It activates the AeroForm Tissue Expander to release the programmed amount of CO2 gas (10cc). The Dosage Controller is configured to provide coded instructions to its bonded AeroForm Tissue Expander. It has a single push button for ease of use and a bank of indicator lights (LEDs) and tones. The Physician Master Key is used only by the physician in the operating room or in the physician office. With the Physician Master Kev inserted into the Dosage Controller receptacle, the Dosage Controller can activate the Expander with no daily limit on the expansion volume.