Archive for August, 2010

New NICE Guidance Will Improve Diagnosis And Treatment Of Chronic Heart Failure

NICEThe National Institute for Health and Clinical Excellence (NICE) has issued its updated clinical guideline on the management of chronic heart failure in adults in primary and secondary care. In taking into account the wealth of new, high quality evidence that has been published since NICE’s original guideline in 2003, the new guideline provides the most comprehensive and up-to-date set of recommendations yet on the diagnosis, treatment, rehabilitation and monitoring of people with this condition.

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Svelte(TM) Medical Systems, Inc. Receives CE Mark Approval To Market The Svelte Acrobat Stent-On-A-Wire (SOAW) Coronary Stent System

Svelte Medical SystemsSvelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

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Mount Sinai Pioneers New Method For Detecting High-Risk Cardiovascular Disease

Mount Sinai School of MedicineResearchers from Mount Sinai School of Medicine have for the first time developed a way to visualize coronary artery plaques vulnerable to rupture using multi-color computed tomography (CT), an innovation that will lead to better and earlier diagnosis of cardiovascular disease. The data are published in the September issue of Radiology. Ruptures of atherosclerotic plaques are the cause of nearly 70 percent of heart attacks.

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FDA Recommends Dropping Low Blood Pressure Drug Midodrine Hydrochloride

Food and Drug AdministrationFDA Recommends Dropping Low Blood Pressure Drug – Midodrine Hydrochloride (ProAmatine) the FDA has recommended withdrawing the approval of ProAmatine (midodrine hydrochloride), a Shire Development Inc. medication for the treatment of orthostatic hypotension  – a temporary drop in blood pressure (hypotension), usually due to suddenly standing up; when standing up the patient becomes dizzy or faints. The FDA says that post-approval studies that verify the clinical benefit of the medication have not been done.

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Researchers Pace Embryonic Heart With Laser

Embryonic HeartScientists at Case Western Reserve University and Vanderbilt University found that pulsed light can pace contractions in an avian embryonic heart, with no apparent damage to the tissue. The work, “Optical pacing of the embryonic heart,” was published in the advanced online issue of Nature Photonics. According to the scientists, this non-invasive device may prove an effective tool in understanding how environmental factors that alter an embryo’s heart rate lead to congenital defects.

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Boston Scientific Begins Clinical Trial Enrollment For New Coronary Stent With Bioabsorbable Polymer And Everolimus Drug Coating

Boston Scientific CorporationBoston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

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GE Healthcare Medical Diagnostics Re-launches Optison(TM) Contrast Agent

GEGE Healthcare Medical Diagnostics announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

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Bayer Rivaroxaban Meets Primary Endpoint In Long-Term Phase III EINSTEIN-DVT Study

BayerBayer announced that a novel, convenient single-drug treatment approach with oral rivaroxaban met the primary efficacy endpoint of non-inferiority in the EINSTEIN-DVT Phase III clinical trial and showed an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT) initial enoxaparin treatment, followed by a vitamin K antagonist. The primary efficacy outcome in this non-inferiority trial was the cumulative incidence of symptomatic recurrent venous thromboembolism.

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Trophos Publishes The Identification And Characterization Of The Novel Cardioprotective Compound, TRO4030

Trophos SATrophos SA has announced that a publication entitled “TRO40303, a new cardioprotective compound, inhibits mitochondrial permeability transition” was published in Pharmacology And Experimental Therapeutics and on-line. The studies reported in the paper demonstrate the potential for this compound to protect heart tissue from ischemia-reperfusion injury induced when treating myocardial infarction. TRO40303 is the second most advanced cholesterol oxime to be discovered by Trophos and will enter clinical development shortly.

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GSK Receives CHMP Positive Opinion For A New Indication For Arixtra

GlaxoSmithKlineGlaxoSmithKline (GSK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis. Fondaparinux is currently approved for use in the EU for the prevention of venous thromboembolic events (VTE).

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