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Hypertension Device Trials, DES Cost Data Headline ACC 2009 In Orlando

This article was originally published in The Pink Sheet Daily

Executive Summary

American College of Cardiology meeting featured “late-breaking trials” of emerging cardiovascular technologies from small companies.

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Ardian Targets 2011 For First Launch Of RF Catheter That Treats Hypertension

Ardian plans to introduce the first catheter-based treatment for uncontrolled hypertension in Europe by 2011 and in the U.S. by 2013

TCT In Brief

PREPARE: St. Jude Medical's Proxis embolic protection device helps to resolve ST-segment elevation faster in patients with ST-elevated myocardial infarction, according to results of the 280-patient Prospective Randomized Trial of Proximal Microcirculatory Protection in Patients with Acute Myocardial Infarction Undergoing Primary PCI (PREPARE) trial, presented at the Transcatheter Cardiovascular Therapeutics scientific symposium on Oct. 15 by Karel Koch, University of Amsterdam. ST elevation refers to the electrocardiographic signal associated with impending infarction. In PREPARE, ST-elevation was immediately resolved in 66% of the patients randomized to percutaneous coronary intervention with embolic protection from Proxis, compared to 50% of patients treated with PCI without embolic protection. After 30 minutes, 75% of Proxis patients and 66% of control patients were out of ST-elevation. There were no complications with Proxis, which was 510(k)-cleared in 2003

Heart Failure Society Meeting In Brief

Rheos diastolic heart failure trial: Minneapolis firm CVRx has begun a 60-patient randomized, double-blind clinical trial of its Rheos baroreflex activation therapy system for treatment of diastolic heart failure, a heart's inability to fully relax and let the ventricle fill with blood, Michael Zile, Medical University of South Carolina, Charleston, said at the Heart Failure Society of America Scientific Meeting in Toronto on Sept. 22. Rheos electrically activates the carotid baroreceptors, the body's natural cardiovascular regulation sensor. All patients in the trial will have heart failure with a left-ventricular ejection fraction of at least 45%. The primary endpoint of the trial will be left-ventricular mass index. The Minneapolis company is also currently sponsoring a 300-patient trial of Rheos to treat drug-resistant hypertension (1"The Gray Sheet" Aug. 4, 2008, p. 14)

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