MedIntelliBase® NewsTips
November 2007
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Table of Contents

1) EVEREST Trial - Pivotal Technology for Chronic Stroke Patients
  • EVEREST - Safety and effectiveness of cortical stimulation
2) SPIRIT III Trial - Taxus and Xience Data
  • SPIRIT III - Trial data leads to FDA review of Xience PMA
3) MedIntelliBase Custom Alerts - updated and more powerful
  • MIB Alerts - A Better Way...to get and use medical industry market intelligence
4) Link of the Month
5) Fun Fact of the Month
6A Better Way...to Access Market Intelligence
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1) EVEREST Trial -- Pivotal Technology for Chronic Stroke Patients
Safety and Effectiveness of Cortical Stimulation


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.

Branded Renova-ST, the device’s core technology, relies on the brain’s ability to deliver cortical stimulation (CS) to other areas deep within the brain without disturbing healthy tissue. Compared to other neurostimulation devices, such as deep brain stimulation (DBS), that rely on penetration of the brain tissue, this device is significantly less invasive. Additionally the Renova-ST device is designed to be temporarily implanted.

"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.

Would you like to have summaries like this pushed to you as they occur via email or RSS? Is there another area of interest where you need current, timely clinical research or technology development information? Click here to learn more about our MIB MarketTracks - A Better Way...to stay up to date.

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2) SPIRIT III Trial -- Taxus and Xience Clinical Research Data
FDA to Review XIENCE DES on November 29


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.

Keep tabs on your competition - get informed when key events like regulatory clearances happen. MIB Alerts provide regular updates on clinical research and technology development in your areas of interest. Click here to learn more about our MIB Alerts - A Better Way...to stay up to date.

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3) MedIntelliBase Custom Alerts - updated and more powerful

MedIntelliBase Custom Alerts
A Better Way...
to get and use medical industry market intelligence.

Customizable Search -  MIB Custom Alerts are tightly focused, completely customizable search agents powered by Human Intelligence™. Our industry experience and insight screen out what you don't want and deliver precisely the types of industry developments you do want.

Precisely Targeted - MIB Custom Alerts precisely target your areas of interest by keeping you continuously updated on relevant market, clinical and technology developments.

Pushed to You - MIB Custom Alerts are regularly pushed to you and your team via email or RSS feeds.

Searchable Archives - Archives of your previous MIB Custom Alerts enable you to do quick retrospective searches to find the exact abstract or announcement you need within seconds.

MIB Custom Alerts is part of MedIntelliBase Medical Industry Market Intelligence Tools: a set of vital tools for biotech and medical device executives enabling you to gain and sustain a competitive advantage.

Your Competitive Advantage
  • You respond to new industry developments in real time - today, not weeks or months later
  • Your company stays one step ahead of the competition
  • You are more effective, freeing your time for other tasks
  • You become the industry expert in your organization

Access MIB Alerts Anywhere

For more information, click here or arrange to meet with us by contacting us.

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4) Link of the Month
  • 10 Steps to Growing a Giant Pumpkin - Whether competing for the largest pumpkin in Kasterlee, Belgium, making congee in China or carving Jack-O-Lanterns in the USA this site will provide you the direction you need to grow a 1000+ pound cucurbita (pumpkin).
    [www.pumpkinnook.com]
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5) Fun Fact of the Month
  • Sweet Potato Pie - This is our first in a series of three health benefits of the potato. Sweet potatoes are rich proteins some of which provide about one-third the antioxidant benefit given by glutathione (produced by the body as an antioxidant). Other benefits include its ability to stabilize blood sugar for diabetics and acting as a source of vitamins A, B6 and C helping with inflammation such as asthma, osteoarthritis and rheumatoid arthritis.
    [www.whfoods.com]
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6) MedIntelliBase Custom Email Alerts & MarketTracks...A Better Way

MIB Alerts
The information you need is just clicks away - click image above to see how.

MedIntelliBase Custom Alerts
Does this "quest for Market Intelligence" sound familiar?
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  2. Agonize over the high prices
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  4. Sort through reams of semi-useful results with every alert
  5. Marvel at the lack of precise targeting and time you spend using your human intelligence to screen-out bad results
  6. Give up and spend hours trying to find the latest developments on Medline or Google
  7. Search for hours to find that one abstract or press release from 3 or 4 months ago that supports your point
  8. Get frustrated at the inability to find what you need
  9. Write your report or your business plan that you know should be better, more in depth and more precise...if only you had better information
  10. Vow that next time, you’ll find a better way
MIB Alerts Flow Diagram
The information you need is just clicks away - click image above to see how.

MedIntelliBase Custom Alerts
A Better Way...to get and use medical industry market intelligence.
  • MIB Custom Alerts precisely target your areas of interest by keeping you continuously updated on relevant market developments.
  • MIB Custom Alerts are tightly focused and completely customizable search agents powered by Human Intelligence™ - harnessing the vast capabilities of search engines by applying our industry experience and insight. Human Intelligence screens out what you don’t want and delivers precisely the types of industry developments you do want.
  • MIB Custom Alerts are regularly pushed to you and your team via email or RSS feeds.
  • Archives of your previous MIB Custom Alerts enable you to do quick retrospective searches to find the exact abstract or announcement you need.
MIB Custom Alerts is part of MedIntelliBase® Medical Industry Market Intelligence Tools, a set of vital tools for biotech and medical device executives – enabling you to gain and sustain a competitive advantage:
  • You respond to new industry developments in real time – today, not weeks or months later
  • Your company stays one step ahead of the competition
  • You become the "industry expert" in your organization
  • You are more effective, freeing your time for other tasks
  • Online – accessible via email, RSS feed, or browser from anywhere
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     MIB Alerts
MedIntelliBase Custom Alerts are highly flexible, customized intelligent search filters powered by "Human Intelligence™" that give you convenient, timely, and tightly focused updates on new developments in your industry segment. MIB Alerts are especially suitable for busy Marketing, Business Development, and General Management executives in medical device and biotechnology companies.
A few examples of thousands of possibilities for Alert topics:

Cardiac, Cardiovascular and Vascular
  • Peripheral Arterial Occlusion (PAO)- Thrombolysis
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  • Lower Limb PAD & Atherectomy
  • PV Angiography - Infusion Catheters
  • CV/PV Angiography - Power Injectors
  • Deep Vein Thrombosis (DVT) - Thrombolysis
Neurology
  • Neurostimulation - Hearing Loss
  • Neurostimulation - Alzheimer's disease
  • Neurostimulation - Parkinson's disease
  • Drugs and Advanced Therapies - Parkinson's disease & Essential Tremor
  • Neurostimulation - Epilepsy
  • Neurostimulation - Pain Management
Orthopedic
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Emergency Medicine
  • Resuscitation
View a sampling of Custom Email Alerts
Customize your Alerts with the type of information you specify:
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You can find more in-depth information about MedIntelliBase Market Intelligence Tools:

 - MedIntelliBase Custom Alerts - MIB MarketTracks -

- MIB SMArtStats - MIB MarketResearch - MIB Customer Needs Analysis -

Visit our website at www.MedIntelliBase.com, request more information on the site, or Contact MedIntelliBase directly.

MedIntelliBase will help you find the critical intelligence you need to make informed product development and business investment decisions.

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MIB NewTips November 2007 Issue – Volume 2, Number 10

** The Next Phase Publishing; a division of Next Phase® Consultancy, Inc.

© The Next Phase® Consultancy, Inc. 2007. All rights reserved.

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