MedIntelliBase® NewsTips September 2007
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Table of Contents


1) European Society of Cardiology Congress – ESC 2007 – Selected Highlights
  a) DES Use in Acute MI - GRACE Registry Experience
  b) BioSTAR - NMT Medical Announces Hints of BEST Trial results


2) Science, Innovation, Synergy - SIS 2007 Conference in Seattle - Selected Highlights
  a) Biomarkers - P4 Medicine -> Predictive, Personalized, Preventative and Participatory Medicine
  b) BioSTAR - NMT Medical Announces Hints of BEST Trial results


3) Cardiovascular Research Institute - CRT 2008 Symposium in Washington, D.C. – February 2008
  • CRT 2008 - An international multi-modular symposium covering a variety of evidence based cardiac and vascular medical disciplines

4) MedIntelliBase Custom Alerts - updated and more powerful
  • MIB Alerts - A Better Way...to get and use medical industry market intelligence

5) Link of the Month

6) Fun Fact of the Month

7) A Better Way...to Access Market Intelligence

8) More Information Available at www.MedIntelliBase.com

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1) European Society of Cardiology Congress 2007 – Selected Highlights


a) DES Use in Acute MI - GRACE Registry Experience

"I believe that what is really needed is a large, long-term randomized trial comparing bare-metal and drug-eluting stents to really answer the safety questions," stated Dr. Gabriel Steg, professor of cardiology and director of the coronary care unit at Hopital Bichat-Claude Bernad Service de Cardiologie (Paris, France) at the conclusion of his talk regarding the use of drug-eluting stents (DES) vs. bare metal stents (BMS) at the European Society of Cardiology (ESC) Congress 2007. At the Hot Line III talk on September 4, 2007 Dr. Steg discussed results from the GRACE (Global Registry of Acute Coronary syndromEs) registry, an international study collecting data from 94 hospitals across 14 countries from North and South America, Europe and Australia/NZ.

Prior to this presentation there has been little published from any of the DES vs. BMS trials discussing the issue in the context of acute coronary syndromes. Dr Steg's talk focused on the acute MI data collected from GRACE. This registry compared the survival up to 2 years of patients solely treated with BMS or receiving at least one DES.

GRACE included more than 56,000 acute coronary syndrome patients. For his presentation Dr. Steg analyzed data from 6,764 patients. Stent placement was at a ratio of 2 BMS:1 DES. Women, obese patients, and those with "more medical history, more diabetes, more ICDs," received higher use of DES according to Dr. Steg. In addition, survival appeared similar in the 6-months following discharge, however, in patients treated with drug eluting stents mortality was greater after 6 months. The patient group treated for acute myocardial infarction highly influenced this result. This result was associated with an increased risk of late reinfarction, likely related to late stent thrombosis.

For a MIB MarketTracks snapshot of this GRACE Registry 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 Alerts - A Better Way...to stay up to date.

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1b & 2b) BioSTAR - NMT Medical Announces BEST Trial Results and UK Market Approval


Six month results from the BEST Trial: 96% of enrolled patients had complete PFO closure

On August 13, following hints of good trial outcomes initially presented at SIS 2007 on August 3, NMT Medical announced the UK launch of the BioSTAR device for the treatment of patent foramen ovale (PFO). A novel bioabsorbable device (acellular collagen matrix on NMT’s STARFlex alloy framework), BioSTAR repairs the heart within 30 days, according to trial data. Comparatively, current treatment technology creates scar tissue and can require up to 6 months for the same results.

At the SIS 2007 conference, several presentations explored the effects of PFO. This cardiac defect is thought to be the cause of stroke and migraine headaches in many patients. In the UK BEST Trial 6 month results showed that 96% of enrolled patients had realized complete PFO closure. Accordingly, in September of 2006 NMT received FDA approval to use NMT's bioabsorbable implant BioSTAR in the U.S. MIST II Trial rather than STARFlex, an older technology, and to change the primary endpoint for that trial from resolution to reduction of migraines.

With the BEST data, UK clearance secured, and additionally the June 2007 Canadian approval of BioSTAR, NMT's next target market is the US market, supported by MIST II Trial data. NMT’s August 7, 2007 press release noted "slower than expected" progress in MIST II enrollment. Now using the new BioSTAR device, first patient enrollment is expected in the third quarter of 2007, with completed patient enrollment expected in early 2008.

For a MIB MarketTracks snapshot of the MIST II Trial and BEST Trial results click the trial names.

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 Alerts - A Better Way...to stay up to date.

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2) Science, Innovation, Synergy - SIS 2007 Conference in Seattle - Selected Highlights


a) Biomarkers – P4 Medicine -> Predictive Personalized Preventative & Participatory

Boldly predicting that "predictive medicine will be realized within 10 years," Dr. Leroy Hood, president and founder of the Institute for Systems Biology in Seattle, WA, opened SIS 2007 as the keynote speaker with a presentation on biomarkers titled, “Predictive, Personalized, Preventative and Participatory (P4) Medicine.” His presentation covered a brief history of the human genome project and the doors that were opened based on that project’s research. Dr. Hood referred to biology as an "informational science," with DNA code and environmental influence as the two pivotal drivers behind this science.

"In the future we will try to re-engineer networks and biological machines as drugs," said Dr Hood. According to Dr. Hood, disease is a result of perturbed biological machines and networks. Understanding every aspect of these machines as they operate in their environment will allow care givers to diagnose and restore system functions.

One major finding Dr. Hood highlighted was a new emphasis regarding blood as a window to health and disease. Acknowledging organ-specific blood markers, he noted that mapping these markers will allow disease “fingerprinting.” This fingerprinting is expected to enable earlier detection and diagnosis than current tools allow.

With the revolutions in data technologies, digitization of biology and doctor-patient relationships, and as costs to administer these elements decrease, the practice of medicine will be altered, evolving to P4 medicine. Doctors will have the ability to diagnose patients with a simple analysis of disease fingerprints from patients’ blood samples. In the future, P4 medicine may be able to reverse the ever-escalating upward trend in healthcare costs, in large part because of a decrease in diagnosis expense and the less costly nature of early treatment.


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) Cardiovascular Revascularization Therapies 2008 Symposium in Washington, D.C.- February 11-13, 2008

Look for several special MIB NewsTips issues over the next few months describing the upcoming CRT 2008 Symposium, to be held February 11-13, 2008 in Washington, D.C. This international multi-modular symposium features a renowned faculty of experts on cardiovascular medicine and intervention from around the world, discussing scientific issues, clinical controversies, and current experiences both pre-clinical and in clinical patient treatment settings. The program consists of 14 concurrent meetings, which are components of the Coronary, Scientific, Endovascular and Technology tracks.

CRT 2008
For more information on this symposium click the CRT 2008 logo.
We hope to see you in Washington, D.C. at CRT 2008.

If you would like to opt-out of these special CRT 2008 newsletters, please reply, noting in the Subject Line, "Decline CRT e-Notices."


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5) Link of the Month
  • Back-to-School Health Resource - Dr Neil Izenberg is the editor and chief of this child friendly health resource site. Along with many other expert reviewers Dr Izenberg is one of many Dr offering youth health tips to site visitors. Perfect for families and young children a current feature on the site is back-to-school health information. [www.kidshealth.org]
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6) Fun Fact of the Month
  • Shall We Dance? - This AARP article highlights the many health benefits of dancing including; bone and muscle strengthening, tone, stamina, posture and balance, increased confidence, stress reduction and more. Why go to the gym when you can dance. [www.aarp.org/health]
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  • MIB Custom Alerts are regularly pushed to you and your team via email or RSS feeds.
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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:
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Neurology
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8) More Information Available at www.MedIntelliBase.com

You can find more in-depth information about MedIntelliBase Custom Alerts - MIB MarketTracks - MIB SMArtStats - MIB MarketResearch - MIB Customer Needs Analysis. Visit the website at www.MedIntelliBase.com, request more information on the site, or Contact MedIntelliBase directly.

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

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