Edwards Sapien Valve Partner Clinical Trial Heart Valve Repair

Edwards Lifesciences Corporation announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter heart valve. The data from The PARTNER Trial (Cohort B) demonstrated a sustained and increasing survival benefit for Sapien valve patients at three years, as well as significantly less time spent in the hospital. The new results were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

November 5, 2012 — ReCor Medical reported one-year follow-up data on patients who have been treated via renal denervation for their resistant hypertension with the company’s Paradise System — the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency energy.

DISCOVER Clinical Trial Direct Medical Trial Direct Flow Medical Transcatheter

Direct Flow Medical Inc. announced that its DISCOVER CE mark trial met its primary mortality endpoint. The study also demonstrated that greater than 95 percent of patients had mild or less aortic regurgitation, and no patients experienced vascular complications. The DISCOVER Trial results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami, Fla.

November 2, 2012 – A clinical trial that compared catheter-based PFO closure using an investigational device found that there was no significant reduction in ischemic and bleeding events compared to standard medical therapy; stroke risk was non-significantly reduced with device therapy.

ADAPT-DES study TCT, 2012, Plavix, stent

November 2, 2012 — Patients who receive a drug-eluting stent (DES) and demonstrate low levels of platelet inhibition are more likely to have blood clots form on the stent and suffer a possible heart attack; conversely, patients with higher levels of platelet inhibition are at greater risk for bleeding complications.

November 1, 2012 — TomTec Imaging Systems GmbH announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 2-D Cardiac Performance Analysis MR (2-D CPA MR) software solution for magnetic resonance imaging (MRI).

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