December 21, 2012 — Covidien announced the five-year results of the ClosureFast long-term European multicenter study in patients with chronic venous insufficiency (CVI). This study evaluates the five-year outcomes of a minimally invasive endovascular therapy for treatment of CVI.

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that the anticoagulant Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves.

Covidien announced that the Solitaire FR Revascularization Device has been approved by Health Canada. The Solitaire FR device is used to restore blood flow to the brain in patients suffering from acute ischemic stroke.

December 19, 2012 — The first patient has been enrolled in the Boston Scientific EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the Synergy stent system and support U.S. Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.

Hospitalized children who suffer cardiac arrest are nearly three times more likely to survive than they were about a decade ago, and no more likely to suffer brain impairment, according to new research in the American Heart Association journal Circulation: Cardiovascular Quality & Outcomes.

December 19, 2012 — CardiacAssist Inc. announced it has received investigational device exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) for a pivotal clinical study of the TandemHeart circulatory support system. The TandemHeart to Reduce Infarct Size (TRIS) trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have suffered a severe heart attack.