Archive for June, 2010

Biosense Webster Gets FDA Clearances For The CartoXPress(TM) Software Module And Lasso(R) NAV Catheter For Its Carto(R) XP System

Biosense WebsterBiosense Webster, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the CartoXPress™ Software Module and the Lasso® NAV Circular Mapping Catheter for use with the Carto® XP Mapping System. These two new innovations provide electrophysiologists who do not have access to the Carto® 3 System, the company’s latest revolutionary 3D Mapping technology, with increased speed and efficiency in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms.

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St. Jude Medical Announces Japanese Approval Of The Therapy Cool Path Ablation Catheter

St. Jude MedicalSt. Jude Medical, Inc. has announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy(TM) Cool Path(TM) Ablation Catheter. This marks the company’s first entry into the irrigated catheter ablation market in Japan. The Therapy Cool Path Ablation Catheter is a thin, flexible tube that delivers radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars.

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Relypsa Starts Open-Label Phase 2 Clinical Study Of RLY5016 For The Management Of Hyperkalemia

RelypsaRelypsa, Inc. has announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company’s lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels. The open-label study of heart failure patients with chronic kidney disease is intended to explore dosing of RLY5016.

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In Arthritis Patients Taking NSAIDs, NT-ProBNP Is A Predictor Of CV Risk

cardiovascular riskThe role of N-terminal pro-B-type natriuretic peptide (NT-proBNP, a protein thought to be a regulator of cardiovascular function) as a robust, non-invasive predictor of cardiovascular (CV) risk in patients with arthritis taking cyclooxygenase inhibitors has been reinforced by the results of a multinational study presented at EULAR 2010, the Annual Congress of the European League Against Rheumatism in Rome, Italy.

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How Genetic Chips May Help Identify New Genes and Molecules Leading to Coronary Artery Disease

DNAResearchers at the University of Leicester, England will use the state-of-the-art genetic techniques to examine DNA from over 20,000 patients with heart disease. The study will help to identify new genes and molecules responsible for Coronary Artery Disease (CAD). This, in turn may help to develop new diagnostic and treatment strategies. Preliminary findings from her research will be presented at the University of Leicester on 24 June.

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Researchers Study Use Of Preoperative Beta-blockers

Vascular Annual MeetingA regional quality improvement effort aimed at increasing the use of preoperative beta-blocker (BB) usage to help prevent postoperative myocardial infarction (POMI) was revealed at the 64th Vascular Annual Meeting® presented by the Society for Vascular Surgery®. This quality improvement effort was implemented at 11 centers participating in participating in the Vascular Study Group of New England (VSGNE) from 2003 through 2008.

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St Jude And Hospitals To Pay Nearly $4 Million To Resolve Fraud Allegations

Pacemaker manufacturer St. Jude Medical Inc. and two hospitals have agreed to pay nearly $4 million to resolve fraud allegations, the Justice Department announced Friday. The Justice Department had accused St. Jude of paying kickbacks to hospitals in Ohio and Kentucky to secure heart-device business. St. Jude is to pay $3.7 million and the hospitals to pay a combined $173,000 to resolve the allegations.

New Pacemaker Makes Vital Diagnostic Test Safer For Heart Disease Patients

A new pacemaker that makes it safe for heart disease patients to have a vital diagnostic test they previously could not has been implanted in the first Tasmanian. Previously Tasmanians with pacemakers in their hearts could not undergo Magnetic Resonance Imaging (MRI) scans used to detect cancer, strokes and other disease. Hobart cardiologist Leigh Bowman says the new MRI-friendly pacemaker will make a big difference as at least half of pacemaker patients will need an MRI in their lifetime.

Portable Defibrillator Helps Police Officer To Save A Bellevue School Teacher

A middle-school teacher was revived after collapsing when a police officer at a Bellevue school on another call helped deploy a defibrillator. As part of a pilot program to improve heart attack survival rates, Bellevue and Kent police officers were issued portable automatic electronic defibrillators and trained in their use in March.

FDA Urgently Recalls AED Battery

The maker of a battery pack used in automated external defibrillators (AEDs) voluntarily recalled more than 5,000 of its units due to potentially fatal errors it causes in devices charged with the battery. The FDA has labeled the recall class I, reflecting the most severe warning and meaning that the affected device has a high probability of causing serious adverse events or death with use.

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