Archive for the 'Diagnostics & Theraputics' Category

Resverlogix Commences Phase 2 Atherosclerosis Clinical Trial

Resverlogix CorpResverlogix Corp. has announced that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix’s oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD). The Cleveland Clinic has named this trial, ASSERT, which stands for ApoA1 Synthesis Stimulation Evaluation in Patients Requiring Treatment for Coronary Artery Disease.

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Moderate weight loss can improve cardiovascular health among obese says study

American College of CardiologyAccording to the findings of a recent study published in Journal of the American College of Cardiology, cardiovascular health of the obese can undergo a notable improvement if they lose some weight by eating less and undertaking more physical activity. The two-year study, conducted by researchers from Washington University School of Medicine in St Louis, found that weight loss in the obese improved some key measures of heart and vascular health.

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FDA approves Boehringer Ingelheim MICARDIS

MicardisThe FDA approves Boehringer Ingelheim’s MICARDIS® (telmisartan) as the first treatment in its class to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients at high cardiovascular risk who are unable to take ACE inhibitors. This new indication is based on The ONTARGET Trial results which showed that MICARDIS® may prevent one in five serious CV events or death from cardiac causes.

FDA clears EnSite velocity Cardiac Mapping System

St JudeThe FDA has cleared the way for St Jude Medical Inc to launch its new EnSite velocity Cardiac Mapping System. The new system has been designed to help doctors diagnose and guide therapy to treat abnormal heart rhythms. The system, used in minimally invasive electrophysiology procedures, uses catheters with electrodes inserted into a cardiac chamber. The electrodes then relay electrical information from the heart in a 3-D anatomical model.

Philips introduces advancements in Xcelera system

PhilipsPhilips has introduced new enhancements to its Xcelera multimodality cardiology image management, analysis and reporting solution. Xcelera R3.1 has new telecardiology capabilities to support clinical workflow and help provide faster sharing capabilities for cardiac patient information. Telecardiology allows remote access to cardiac information, including from a home office computer, image sharing with referring physicians and the ability to access Xcelera functionality through other applications such as an electronic health records (EHR) system.

FDA approves Effient for thrombotic cardiovascular

Daiichi Sankyo Inc and Eli Lilly received approval from the US Food and Drug Administration (FDA) for Effient (prasugrel) tablets to be used for the reduction of thrombotic cardiovascular events. Effient reduces thrombotic cardiovascular events (including stent thrombosis) in patients suffering from acutecoronary syndromes and undergoing an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

Cialis’ active ingredient approved for a new use

The FDA has approved tadalafil, the active ingredient in the erectile dysfunction drug Cialis, to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder. This disorder causes high blood pressure in lungs. Tadalafil, manufactured by the drug company Lilly, will be available in the U.S. as Adcirca in August by United Therapeutics Corporation.

Darapladib in conjunction with statin drugs may reduce risk of heart attacks and stroke

HeartResearchers have indicated that an enzyme found in coronary plaques may be responsible for significant number of cardiac patients suffering from heart attacks and stroke, despite the widespread use of cholesterol-lowering drugs. The enzyme makes plaque more vulnerable to rupture and block blood flow. According to new research, the drug darapladib, taken in adjunct to the treatment of statin drugs, may offer a way to fight that risk as it safely and effectively lowers the activity of the Lp-PLA2 enzyme.

Photo by Patrick J. Lynch

FDA to continue regulating Vasogen Celacade system

Celacade logoThe FDA has decided to continue to regulate Vasogen’s Celacade system as a medical device. The Celacade system is a treatment for patients with New York Heart Association (NYHA) Class II heart failure. The FDA’s Center for Biologics Evaluation and Research (CBER) is to take over as the lead reviewer of the programme. The CBER has informed Vasogen that it does not agree with the use of a Bayesian approach in the ACCLAIM II study of the system. The FDA had earlier recommended the design.