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Valence Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan.

The Valence Robotic Navigation System is indicated for assisting surgeons in spinal procedures, such as:

• Pedicle screw placement
• Interbody device placement

Valence Robotic Navigation Instruments (for use with the StealthStation™):

The Valence Posterior Disc Prep Instruments are indicated to facilitate discectomy, bony resection, and implant selection during spinal surgery.

The Valence Posterior Fixation Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.

Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Valence Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing pedicle screws and interbody implants in the thoracolumbar and sacral spine.

The system uses optical instrument tracking and registration to an intraoperative 3D scan to navigate patient anatomy across three independent workflows:

• Robotic assisted screw navigation
• Freehand screw navigation
• Freehand disc prep and interbody implant navigation

In addition to compatibility with the Valence Robotic Navigation System, select instruments referred to as Valence Robotic Navigation Instruments (for use with StealthStation™) are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection while the posterior fixation instruments are intended to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

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