Researchers 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 (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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Scientists 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 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 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 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 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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GlaxoSmithKline (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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Acorda Therapeutics, Inc. has announced the National Heart, Lung, and Blood Institute (NHLBI) has awarded a $1 million Cardiac Translational Research Implementation Program (C-TRIP) grant to support research on Glial Growth Factor 2 (GGF2), a novel investigational agent for the treatment of patients with heart failure under development at Acorda. The grant, supporting both clinical and laboratory studies, was awarded jointly to Acorda and Vanderbilt University Heart and Vascular Institute.

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The U.S. FDA (Food and Drug Administration) announced it has approved the 1st generic version of enoxaparin sodium injection (Lovenox), an anti-coagulant (blood thinner) used for the prevention of DVT (deep vein thrombosis), as well as some other therapies. Lovenox is made from heparin and was approved for use in the USA in 1993. It is a blood-thinning medication whose active ingredient is a naturally-derived complex mixture of sugar molecules.

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