The firm will begin marketing the navigation and imaging system in early 2011.
1 September 10 11:44, Hillel Koren
Mazor Surgical Technologies Ltd. (TASE:MZOR) has obtained US Food and Drug Administration (FDA) approval for the company’s combined spinal surgical system comprising the SpineAssist miniature robotic navigation system and C-Insight 3D imaging system. More »
Mazor said the successful new application for the SpineAssist – surgical procedures on neck vertebra through the nape of the neck – supplemented its current use for surgical procedures on the spine in the lower and middle back.
Surgery on the neck vertebrae is considered extremely difficult and complicated because of the great risk of paralysis if the spinal cord is damaged during the procedure. Neck vertebrae procedures account for 30% of all spinal surgeries. Some of the procedures involve the insertion of implants into spinal cavities that are only a few millimeters in diameter and which contain critical nerves and arteries to the brain.
The surgery on the neck vertebrae was carried out in Germany on a patient with severe trauma of the vertebrae. The medical team used SpineAssist to navigate the location to position four titanium pins in the vertebrae. The procedure took two hours, and was completed with no complications and to the complete satisfaction of the medical team.
Published by Globes [online], Israel business news – www.globes-online.com – on July 7, 2009
Caesarea Israel, May 25th, 2009 – Mazor Surgical Technologies Ltd. (TASE: MZOR) announced today that it is expanding its
GO-LIF – Guided Oblique Lumbar Interbody Fusion clinical trial in Europe & Israel, following the CE mark approval for GO-LIF and the latest results of the biomechanical and pilot clinical studies presented at SAS London proving GO-LIF’s safety and efficacy in spine stabilization. These studies presented at SAS London by Dr. Isador Lieberman and Dr. Selvon St. Clair of the Cleveland Clinic Foundation in the US, highlighted the biomechanical superiority, safety and feasibility findings concluded from recent extensive biomechanics studies.
GO-LIF – Guided Oblique Lumbar Interbody Fusion is an innovative spine surgical procedure developed by Mazor in partnership with the Cleveland Clinic Foundation, under a strategic joint development agreement signed in April 2008. This procedure enables spinal fusion by insertion of the GO-LIF MFS proprietary screws into the patient’s vertebra using a minimally invasive surgical technique and accurate guidance provided by SpineAssist®, Mazor’s miniature robotic device.
The GO-LIF construct consists of 2 proprietary screws replacing the traditional 4 screws & 2 rods construct for spine stabilization.
GO-LIF procedures may be performed using straight-forward open, minimally invasive and percutaneous approaches to stabilize the lumbar spine in conjunction with spinal fusion.
For patients, the GO-LIF procedure provides significant clinical benefits including:
- Bio-mechanical superiority, as the screws neutralize the instantaneous axis of rotation.
- Sparing soft and hard tissue including pedicles within the stabilized construct.
- Reducing the risk of muscle and nerve irritation due to less metal implants in the body.
- Benefits associated with a minimally invasive and percutaneous procedure.
The first GO-LIF procedure was successfully performed 6 months ago at Carmel Hospital, Israel by Dr. Bruskin and Dr. Silberstein. The patient was able to return to normal routine after only 72 hours and the 6 month follow-up x-ray clearly showed that the construct is intact. Since then, several cases have been performed both in Germany and Israel.
An international multi-center clinical trial has successfully commenced in 8 centers in Germany and Israel and additional centers such as Switzerland will join shortly, pending hospital IRB and ethical committee approvals. Mazor is in the process of identifying 10 additional centers, which may be interested and qualified to participate in the GO-LIF study.
For more information regarding GO-LIF or to express interest in joining the clinical study, please contact – Mr. Guy Auerbach,
GO-LIF Product Manager at guy@mazorst.com
About Mazor Surgical Technologies
Founded in 2001, Mazor Surgical Technologies is dedicated to the bringing to the market innovative medical devices including, orthopedic & spine surgical procedures and 3D imaging. Mazor’s proprietary technologies enable a safer surgical environment for patients, surgeons and OR staff, by utilizing miniature robotic, imaging and implant technologies. Mazor’s corporate headquarters is located in Caesarea, Israel and regional offices are located in the US and Germany. Other worldwide geographies are supported by distributors.
For more information, please visit us at www.mazorst.com or contact us at info@mazorst.com.
Forward Looking Statements
This press release contains information regarding continuation of GO-LIF development, its marketing and additional usage, which is forward looking information according to the stock market law of 1968 that is based on the data, which the company withholds as of this report date. There is no certainty regarding continuation results of development of the GO-LIF procedure, its marketing options or usage that may be caused by external factors that are not controlled by the company.
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