Spine Planning

Using the System

Intended Use and Indications for Use/Intended Purpose

The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s preoperative or intraoperative 3D image data.

The Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools.

The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image and 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Known Contraindications

There are no known contraindictions for the use of this device.

Place of Use

The planning tasks shall be performed in an office or in the operating room.

The navigation tasks shall be performed in an operating room/suite.

User Profiles

Neuro / Ortho / Spine / Trauma surgeons or their assistants having a 3D image acquisition system (such as CT or 3D C-arm), or utilizing preoperatively acquired CT / CT like (and potentially fused MR) imaging data in combination with a Brainlab navigation system.

Patient Population

The patient population includes any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, 3D fluoroscopic image reconstruction).

Clinical Benefit

The Spine & Trauma Navigation System provides the following benefits:

  • Higher accuracy in placement of screw implants in comparison to conventional techniques

  • Reduced radiation dose for the operating staff in comparison to conventional techniques

  • Lower (intra-operative and post-operative) complication rate due to misplaced screws in comparison to conventional techniques

  • The need for the patient to return to the operating room for revision surgery is reduced or eliminated

Plausibility Review

Warning
Art-No. 60920-06EN

Fecha de elaboración: 2020-03-09