Final Patient Completes Four Week Follow-up ... Northstar Neuroscience (Seattle, Washington) announced on October 25 that the final patient in its EVEREST multi-center Phase III pivotal trial has completed the four week follow-up, the primary endpoint for the trial. As the active therapy in the treatment leg of the trial, Northstar’s neurostimulation technology could yield a novel, less invasive option for the treatment and rehabilitation of stroke patients, assuming approval by the FDA.

"EVEREST is a landmark trial, the largest study of its kind, and we expect it to yield a wealth of clinical data regarding Northstar’s Renova-ST cortical stimulation therapy," according to John Bowers, Northstar’s President and CEO in the October 25 press release. EVEREST is a national, U.S. trial and includes 21 sites from Florida to Washington state with 151 patients enrolled. Data will be analyzed along with that data from an additional 12 sites from Northstar’s previous BAKER Trial. Mr. Bowers added, "We anticipate releasing EVEREST primary efficacy and safety data in the first half of December, and continue to plan for submission of our premarket approval application by the end of the year."

As part of the trial protocol the device was removed after an 8 week follow up. Design of the Renova-ST therapy for stroke patients includes conjoining physical rehabilitation allowing the patient to make significant motor and speech recovery. For a MIB MarketTracks snapshot of this EVEREST Trial results click the trial name.

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November 5, 2007 -- FDA Confirmation... A Circulatory Systems Devices Advisory Panel meeting will be held on November 29, 2007 to review the XIENCE V Everolimus Eluting Coronary Stent System PMA. Filed on June 1, 2007 by Abbott Vascular (Redwood City, California), the PMA was supported by data from the SPIRIT II and III Trials. Clinical evaluation data was provided by the SPIRIT III Trial. This trail compared the XIENCE to the TAXUS stent manufactured and marketed by Boston Scientific Corporation (Boston, Massachusetts). XIENCE was developed by Guidant Corporation prior to its acquisition by Boston Scientific and Abbott Vascular.

Regarding the SPIRIT II trial results published in 2006, BSCI welcomed the trial's affirmation of the strength of the TAXUS stent. According to Jeff Goodman, President of Boston Scientific, "SPIRIT II adds to the extensive body of evidence from randomized trials that reinforce the excellent safety and efficacy of the TAXUS Stent System and provides solid traction for growth of the PROMUS Stent. the TAXUS Stent continues to demonstrate exceptional deliverability and the proven clinical outcomes that make it the leading drug-eluting stent in virtually every market where we offer the product."

More on the SPIRIT III Trial results can be viewed by clicking the trial name. We will report on the outcome of this FDA Panel meeting in our December MIB NewsTips issue.

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MIB NewTips November 2007 Issue – Volume 2, Number 10

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