Archive for July, 2010

Acorda Therapeutics Announces Receipt Of NIH Grant For Development Of GGF2 In Heart Failure

Acorda TherapeuticsAcorda 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.

Read the full story here

FDA Approves First Generic Blood Thinner Enoxaparin Sodium Injection

Food and Drug AdministrationThe 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.

Read the full story here

BioSTAR(TM) Device Achieves 90 percent Closure Rate For Atrial Septal Defect In Children

Atrial Septal Defect In ChildrenA study by Canadian physicians reported that the BioSTARTM biodegradable implant achieved comparable closure rates to the Amplatzer Septal OccluderTM (ASO) in children with atrial septal defect (ASD). The BioSTAR device displayed successful outcomes, while avoiding issues associated with implants containing metal. Results of the study, the first to compare the BioSTAR device with the ASO in children, are now available online and in the July print issue of Catheterization and Cardiovascular Interventions.

Read the full story here

NICE Publishes Final Draft Guidance On The Use Of Dronedarone For Treating Atrial Fibrillation

NICEThe National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dronedarone (Multaq) for the treatment of atrial fibrillation (AF) – a disturbance of the heart’s rhythm. In its final draft guidance, NICE has reaffirmed the decision in its previous draft to recommend the limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy.

Read the full story here

Use Polysomnography To Diagnose Obstructive Sleep Apnea: Research

Sleep2010Obstructive sleep apnea is a frequent comorbidity in patients suffering from atrial fibrillation, and polysomnography should be used to diagnose it. According to a research presented at SLEEP 2010: Associated Professional Sleep Societies 24th Annual Meeting, portable diagnostic methods underestimate the incidence of obstructive sleep apnea in these patients.
Read the full story here.

Medtronic Fixing Defibrillator For Battery Issue

MedtronicMedtronic Inc.’s Physio-Control subsidiary said that it has launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem, and that one patient may have died as a result. The FDA said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors are at issue worldwide.

Read the full story here.

FDA Issues Class I Recall for Physio-Control’s LifePak 20/20e Defibrillators

The Food & Drug Administration has slapped Medtronic Inc’s subsidiary Physio-Control Inc. with a Class I recall of its LifePak 20/20e defibrillators after the company declared a “field correction” for a battery problem last week. Physio-Control issued a “field correction” on July 2, after discovering that some of the devices might lose battery power while in operation.

FDA Approves Expansion of Endologix’s Main Product Line

Endologix Inc said that the Food and Drug Administration has approved the expansion of its main product line. The FDA approval covers 31 new sizes of its Powerlink stents, which it said should expand the number of patients they can be used on by to 5% to 10%. Endologix’s stents are used to reinforce a ruptured or ballooning section of an artery.