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Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic’s Prestige disc was approved for market launch. Under the conditions for Bryan’s approval, Medtronic will conduct a 10-year post-market study tracking patients’ neck disability index scores, radiographic information, neurological status and a number of other outcomes in addition to data on adverse events and explanted devices.

The Bryan is made from titanium and polyurethane, which is softer than the nuclei of competitive discs and designed to better mimic natural disc shock absorption. The polyurethane raised questions on wear debris during the FDA panel, and though it was found not to be an issue in the short-term, it would require long-term surveillance. In comparison, the Prestige is metal on metal, and Synthes’ ProDisc-C is metal on polyethylene.

Bryan will join the Prestige and ProDisc-C to round out the current U.S. cervical disc offering, which is anticipated to expand to include devices from LDR, NuVasive and others. Medtronic has not commented on the Bryan’s approval nor on projected launch dates. In the approval letter, the FDA said Medtronic would have to provide a PMA amendment with updated product labeling before the device is distributed commercially.

BY JOHN MCCORMICK, MAY 29, 2009

GAITHERSBURG, Md., May 14 (Reuters) – A U.S. Food and Drug Administration advisory panel recommended expanding approval of Covidien Ltd’s (COV.N) Duraseal sealant for use in spinal surgeries as long as the company gathers more data.The panel of outside experts voted 4-0 in favor of the product, which is already FDA-approved for use in cranial surgeries. The agency will weigh the panel’s recommendation in making its final decision.

Covidien is seeking FDA approval to more widely market Duraseal, a synthetic polymer that is sprayed onto the surgical site to provide a watertight seal, for use in addition to traditional sutures.Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection.

But surgical sutures alone can leave small gaps. Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks. Panelists expressed some concern about the product, saying there was no clear difference in fluid leakage 90 days after surgery, even though the data showed Duraseal worked better than alternative methods during surgery itself.

If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said. Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours.

The company looked at 158 patients, with 102 given Duraseal and 56 treated with other methods, according to the FDA. Covidien spokeswoman Diana Sousa could not say when the company expected the FDA to make a decision. The company declined to give Duraseal’s current revenues for cranial use but said more than 1.6 million U.S. spine surgeries are likely in 2009, citing MedTech Insight data.

(Reporting by Susan Heavey; Editing by Phil Berlowitz and Tim Dobbyn)

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.

A bullied teenager cruelly nicknamed ‘The Hunchback of Notre Dame’ because her spine was twisted by 90 degrees can finally stand up to her tormentors after undergoing life-saving surgery.

Jessica Bishop, 14, was bent-double after scoliosis twisted her spine ‘like a corkscrew’.

The curve left her so hunched to the right that her ribs were resting on her hips.  Her lungs were being crushed – leaving them working at just 60 per cent capacity – and she lost two inches in height.

She was warned that without surgery her spine could become paralysed and even die if left untreated.

Heartless bullies taunted 4ft 6in Jessica about her mis-shapen back and hobbled walk – branding her ‘The Hunchback’.

Devastated Jessica endured months of cruel jibes and she cried herself to sleep at her home in Kidderminster, Worcs.

But now Jessica is standing 2 inches taller after undergoing an 11-hour operation at Birmingham’s Royal Orthopaedic Hospital

Jessica was diagnosed with scoliosis 16 months ago when she was having a dress fitted and the tailor spotted her crooked shoulders.

She was due to have the op just before Christmas but because of a backlog of patients she was told she would have to wait four more painful months.

During that time her spine continued to twist out of shape and she had to prop herself up on five pillows in order to get a good night’s sleep.

She could only walk by shuffling sideways to relief the pressure on her hips and doctors feared her heart was at risk because her ribs were squashing her arteries.

Jessica was finally admitted to hospital in March when a team of five specialists performed an 11-hour operation on her back.

The angle of her spine was reduced by 62 degrees to 28 degrees and it is hoped that the metal plates will prevent any future bending.