ClarifEye

    ClarifEye Augmented Reality Surgical Navigation

     

    When you are performing delicate tasks in the spine, accuracy is paramount to achieving the best outcome for your patients. Philips introduces the new ClarifEye solution, to help you improve surgical precision.

    Step into a new dimension

    Are you interested to learn from clinical experts?

    Join us for a special education event about advanced imaging and navigation solutions for open and minimally invasive spine surgery.

    March 11 | 3:00 - 4:30 PM CET

    Moderator

    Prof. Dr. Y.P. Charles

    Prof. Dr. Y.P. Charles, MD,

    PhD

    Hôpitaux Universitaires de

    Strasbourg, France

    Presenters

    Prof. Dr. A. Seekamp, MD

    Prof. Dr. A. Seekamp, MD,

    PhD

    UKSH, Kiel, Germany

    Schleswig-Holstein

    Prof. Dr. P. Gerdhem

    Prof. Dr. P. Gerdhem MD, PhD

    Karolinska University

    Hospital, Stockholm Sweden

    Dr. P. Scarone

    Dr. P. Scarone, MD

    Ente Ospedaliero Cantonale

    (EOC) Lugano, Switzerland

    Hear Dr. Elmi-Terander experience’s with ClarifEye for spinal deformity open procedures in a Hybrid OR.
    The first clinical experience
    Learn how Dr. Scarone is using ClarifEye for minimally invasive transforaminal lumbar interbody fusions in a hybrid OR
    The next generation of confidence

    Advanced imaging and surgical navigation in a hybrid OR for complex spine procedures

     

    ClarifEye is an industry-first solution that combines imaging and augmented reality (AR) navigation into one system.

    Surgical navigation
    Four high-resolution cameras in the C-arm Flat Detector (A) automatically detect the non-invasive patient markers (B) to augment the surgical field.  The live video images provided by the cameras are overlaid on 3D cone-beam CT (C) The systems visualizes the tip of the ClarifEye Needle as it is navigated along the planned path on the spinal anatomy (D).

    Key benefits of ClarifEye

     

    • Imaging and navigation into one
    • High quality Intra-operative cone-beam-CT imaging at low dose
    • Non-invasive patient tracking streamlines workflow
    • Live augmented reality needle guidance to support precision

     

    Click here to learn more about the key features and benefits of ClarifEye.

    Augment precision and
    patient safety

    Precision white
    94% navigated vs 89.6% freehand improvement in clinical accuracy of pedicle screw placement1

    Excellent image quality

    at lower dose

    Image quality white
    A comparison of radiation dose and image quality during intraoperative spine surgery.

    Perform procedures simply
    and easily

    Easy white
    100% of the users found the system user-friendly2
    Spinal fusion with workflow clarifeye

    Want to see how ClarifEye improves workflow and accuracy in a live demo or speak to an expert?

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    Final CEE consent

    Clinical and pre-clinical evidence

    Clinical accuracy

    Augmented reality navigation with intraoperative 3D imaging vs fluoroscopy-assisted free-hand surgery for spine fixation surgery

     

    94% Navigated vs 89.6% Freehand improvement in clinical accuracy of pedicle screw placement

     

    > Elmi-Terander at el, Augmented reality navigation with intraoperative 3D imaging vs fluoroscopy-assisted free-hand surgery for spine fixation surgery, a matched-control study, Nature Sci. rep. 2020 Jan 20;10(1):707.

    Pedicle Screw Placement Using Augmented Reality Surgical Navigation With Intraoperative 3D Imaging

    An overall accuracy of 94.1% of primarily thoracic pedicle screws was achieved. 

     

    > Adrian Elmi-Terander, at el, Pedicle Screw Placement Using Augmented Reality Surgical Navigation With Intraoperative 3D Imaging, First In-Human Prospective Cohort Study, SPINE Volume 44, Number 7, Nov 2018.

    Screw insertion in the thoracic and lumbar spine with a new tracking device

     

    The overall accuracy of ARSN was 94% compared with an accuracy of 88% for fluoroscopy

     

    > Simon Peh, at el, Accuracy of augmented reality surgical navigation for minimally invasive pedicle screw insertion in the thoracic and lumbar spine with a new tracking device, Cadaveric laboratory study, The spine journal, Volume 20, ISSUE 4, P629-637, Apr 01, 2020.

    Surgical workflow

    Spine Surgery in a Hybrid Operating Room: Design, Workflow, and Clinical Applications

     

    Navigated interventions were performed with a median total time of 379 min per procedure (range 232-548 min for 4-24 implanted pedicle screws).

     

    > Erik Edström, at. el, A Novel Augmented-Reality-Based Surgical Navigation System for Spine Surgery in a Hybrid Operating Room: Design, Workflow, and Clinical Applications Operative Neurosurgery, Oper Neurosurg (Hagerstown). 2020 May 1;18(5):496-502.

    Machine learning for automated 3D segmentation of the spine and suggested placement of pedicle screws

     

    The clinically relevant pedicle identification and automatic pedicle screw planning accuracy was 95,4%. The mean time (± SD) for automatic segmentation and screw planning in 5 vertebrae was 11 ± 4 seconds.

     

    > Gustave Burström, at el, Machine learning for automated 3-dimensional segmentation of the spine and suggested placement of pedicle screws based on intraoperative cone-beam computer tomography, J Neurosurg Spine. 2019 Mar 22;31(1):147-154.

    Radiation exposure

    Radiation dose and image quality comparison during spine surgery with two different, intraoperative 3D imaging navigation systems

     

    Up to 3.7 times higher contrast-to noise-ratio and up to 83% lower X-ray dose compared to mobile Cone-beam CT.

     

    > Rami Nachabe, at. el, Radiation dose and image quality comparison during spine surgery with two different, intraoperative 3D imaging navigation systems, J Appl Clin Med Phys. 2019 Feb;20(2):136-145.

    Augmented Reality Surgical Navigation in Spine Surgery to Minimize Staff Radiation Exposure

     

    When compared to existing literature, ClarifEye substantially lowers the staff radiation dose, without concomitantly increasing patient radiation exposure.

     

    This is achieved by

    • Providing improved image quality at low dose
    • Imaging more spinal  levels in the same scan, avoiding the need for multiple scans

     

    > Erik Edström. at el, Augmented Reality Surgical Navigation in Spine Surgery to Minimize Staff Radiation Exposure., Prospective observational study, SPINE: Jan 1, 2020 - Volume 45 - Issue 1 - p E45-E53.

    Augmented reality and artificial intelligence-based navigation during percutaneous vertebroplasty: a pilot randomised clinical trial

     

    AR/AI-guided percutaneous vertebroplasty appears feasible, accurate and safe, and facilitates lower patient radiation exposure compared to standard fluoroscopic guidance.

     

    > Pierre Auloge, at el, Augmented reality and artificial intelligence-based navigation during percutaneous vertebroplasty: a pilot randomised clinical trial, European Spine Journal Volume 29, Jul 2019.

    For the availability of ClarifEye Augmented Reality Surgical Navigation, please check with your local Philips sales representative.

    Elmi-Terander A. at el. Augmented reality navigation with intraoperative 3D imaging vs fluoroscopy-assisted free-hand surgery for spine fixation surgery: a matched-control study comparing accuracy. Sci Rep. 2020 Jan 20;10(1):707.

    Results obtained during a Usability Evaluation with clinical users (neurosurgeons, orthopedic surgeons, x-ray technologists and OR nurses) in a simulated use environment.

     

    * ClarifEye is not available for sale in the U.S.A. Pending 510(k)