News

Study Supports Stent-Assisted Coiling of Intracranial Aneurysms

May 1, 2013—Findings from an analysis of stent-assisted coiling of intracranial aneurysms in 508 patients at a single center were published by Nohra Chalouhi, MD, et al in Stroke (2013;44:1348–1353).

Spectranetics Finalizes EXCITE ISR Adjunct Analysis Plan

May 6, 2013—Spectranetics Corporation (Colorado Springs, CO) announced that the US Food and Drug Administration (FDA) has approved the company’s adjunct analysis plan associated with the EXCITE ISR clinical trial, which is studying the treatment of in-stent restenosis (ISR) in the legs. The company stated that the goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon percutaneous transluminal angioplasty (PTA) compared with PTA alone before full enrollment of the EXCITE ISR study.

Study Examines Associations of MRI-Measured SFA Occlusions With Functional Performance and Collateral Vessel Number in PAD

May 6, 2013—The Journal of the American College of Cardiology (JACC): Cardiovascular Imaging announced the publication online ahead of print of a study by Mary M. McDermott, MD, et al of the associations of magnetic resonance imaging (MRI)-measured superficial femoral artery (SFA) occlusions with functional performance, leg symptoms, and collateral vessel number in peripheral artery disease (PAD). The investigators studied associations of collateral vessel number with functional performance in PAD.

FDA Approves CSL Behring’s Kcentra for Urgent Warfarin Reversal in Patients With Acute Major Bleeding

April 30, 2013—CSL Behring (King of Prussia, PA) announced that the US Food and Drug Administration (FDA) approved the company’s Kcentra, a nonactivated, 4-factor, human prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (eg, warfarin) therapy in adult patients with acute major bleeding. In December 2012, the FDA granted Orphan Drug Designation for Kcentra for the treatment of patients needing urgent reversal of vitamin K antagonist therapy due to major bleeding and/or surgical procedures.

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