MedIntelliBase® NewsTips
Nov/Dec 2006

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~~~Happy Holidays from MedIntelliBase!~~~
Table of Contents

Endovascular Therapeutics
  • FAST Trial - Bard Peripheral Vascular Luminexx nitinol stent
Endovascular Therapeutics
  • THUNDER Trial - Bavaria Medizin Technologie GmbH Paccocath paclitaxel coated balloons
Carotid Therapeutics & Stroke Prevention
  • PROGUARD Trial - Kensey Nash TriActiv ProGuard Embolic Protection System
Drug-eluting stents (DES) Late Thrombosis - Is there additional risk when compared to Bare Metal Stents (BMS)? Free Personal Tour - MedIntelliBase™ Alerts 
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New MedIntelliBase™ Alerts Link of the Month
  • Nitric Oxide - Explore its role in major medical problems from cardiovascular disorders to Alzheimer's disease...
Fun Fact of the Month MedIntelliBase MarketTracks and Alerts>>
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Endovascular Therapeutics

FAST trial
The FAST (Femoral Artery Stenting Trial) evaluated the Bard Luminexx 3 vascular stent vs. balloon angioplasty (PTA) in 224 patients with superficial femoral artery (SFA) disease. The study's primary endpoint was binary restenosis at 12 months. FAST failed to demonstrate the superiority of the Luminexx stent over PTA in terms of the primary endpoint of binary restenosis in SFA lesions (length 1 to 10 cm). However, stent placement appeared to be associated with a tendency towards a lower risk of restenosis in a wide variety of patient and lesion subgroups, warranting further prospective randomized trials in these patient cohorts including diabetics and patients with total occlusions.

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Endovascular Therapeutics

The THUNDER trial (Local Taxan with sHort time contact for redUctioN of restenosis in Distal artERies) evaluated the use of Bavaria Medizin Technologie GmbH Paccocath paclitaxel coated balloons in the treatment of peripheral artery disease (PAD). The study evaluated 154 patients assigned to treatment with an uncoated control balloon (n=54), an uncoated balloon + lopromid-paclitaxel (n=52), or a paclitaxel-coated balloon (n=48). Binary restenosis at 6 months was significantly reduced with the Paccocath compared to the uncoated balloon group (7/41 vs. 21/54, respectively, p<0.01). It was concluded that the Paccocath is safe and this study offered the first proof that drug-coated balloons can reduce restenosis in the treatment of SFA lesions. Follow-up is planned at 12 and 24 months.

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Carotid Therapeutics & Stroke Prevention

The PROGUARD (Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System) trial is the phase III pivotal study for the Kensey Nash TriActiv ProGuard Embolic Protection System. The TriActiv Proguard is an embolic protection device that temporarily blocks circulation through distal and proximal balloon deployment to the lesion and clears emboli by flushing the target area. This device is already approved for use in the SFAs and studied in the PRIDE trial. The PROGUARD trial is a non-randomized, open label, single group assignment safety and efficiency trial. Expected total patient enrollment is 400.

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These MedIntelliBase™ MarketTracks titles are newly updated:

  • Cardiovascular (CV) Therapeutics
  • Endovascular (EV) Therapeutics
  • Carotid (Carotid) Therapeutics & Stroke Prevention
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Drug-eluting stents (DES) - is there additional risk of late stent thrombosis when compared with bare metal stents (BMS)?

Stay tuned for our January 2007 MIB NewsTips issue for updated coverage of DES late stent thromobsis developments...

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Free Personal Tour - MedIntelliBase™ Alerts

MIB Alerts
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Link of the Month
  • Nitric Oxide. - Possibly best known as a pollutant found in automobile exhaust, learn about Nitric Oxide (NO) through the research of biochemist Tadeusz Malinski and his nanosensor that measures NO within the human body. [Perspectives - Ohio University]
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Fun Fact of the Month
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MedIntelliBase MarketTracks and Alerts >> A Better Way ...

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