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The Axxent Balloon Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Axxent Balloon Applicator is a component of the Axxent Electronic Brachytherapy System, which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver intracavitary or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Balloon Applicator is provided in five sizes to ensure proper fit into treatment areas of varying shapes and sizes. The applicators are disposable and provided sterile.

To shape the beam from a low energy radiation therapy source up to 50kVp.

The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT). The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm. The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.

The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.

The Axxent Surface Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniaturized x-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver high-dose rate, low energy radiation treatment to skin and tissue surfaces. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Surface Applicator is provided in multiple circular aperture sizes to accommodate a range of lesion sizes. The applicators are reusable and sterilizable. Single use disposable end caps are provided to help flatten the treatment surface.

The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy. The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.

The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.

The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.

The Axxent Electronic Brachytherapy System (System) consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxent-compatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller. The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.

The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. The safety and effectiveness of the Axxent Electronic Brachytherapy System as a I he salely and chectryedies of the ristion in the treatment of breast cancer has not been established.

The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source. The Controller is a mobile platform that is responsible for the overall operation of the device. The radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of the appropriately-sized Balloon Applicator. The System is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical marqins following lumpectomy for breast cancer. The Axxent Electronic Brachytherapy System does not utilize a radioactive isotope, or require an HDR isotope afterloader, and thus does not require the heavily-shielded treatment rooms necessary for the delivery of isotope-based HDR brachytherapy.