Clinical trials to study the efficacy of a novel cardiac viability imaging agent is now underway. FluoroPharma, Inc., an affiliate of QuantRx Biomedical Corp., has developed CardioPET as a means to assess acute and chronic coronary artery disease while patients are at rest.

Entry into Phase I trials follows FluoroPharma's filing with the FDA of an investigational new drug (IND) application for CardioPET, the company's first such application.

FDA has accepted ARIXTRA (fondaparinux sodium) Injection for priority review — the anticoagulant supplemental drug developed by GlaxoSmithKline achieved positive results from two pivotal, Phase III trials (OASIS 5 and 6) that evaluated ARIXTRA in the treatment of a broad spectrum of patients with acute coronary syndromes (ACS).

Abbott Vascular says it will begin launching its XIENCE V stent system immediately in most European countries, focusing commercial, manufacturing and clinical resources on this product.

"The positive, differentiating clinical results that XIENCE V demonstrated in SPIRIT II, combined with positive physician feedback about XIENCE V, indicates that XIENCE has significant potential to meet critical next- generation drug-eluting stent needs for physicians and patients," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular.

The genesis of the Abaxis Piccolo technology began with NASA, where scientists sought to develop and manufacture a small biochemical analyzer for use in space laboratories. Abaxis acquired the exclusive patent rights and developed an analyzer that was capable of performing multiple blood chemistry tests based on centrifugal and capillary technology.

SmartPumps are tourniquet systems offering OR connectivity, superior performance, exceptional battery life and intuitive cuff controls.
They support today’s paper chart environment with an optional Tourniquet Report Printer that automatically documents intraoperative tourniquet data. This report is printed on a 2-by-3-inch self-adhesive label.
As the OR evolves, it can communicate with Clinical Information Systems (CIS) and is forward compatible with fully integrated operating rooms.

A retrospective study at Northwestern University Feinberg School of Medicine, Chicago, showed that dialysis patients who had implantable cardiac defibrillator (ICD) therapy were more likely to receive appropriate shocks for ventricular tachycardia or ventricular fibrillation — but they also had worse survival compared with a nondialysis cohort, according to Medscape Medical News.

Catheters of all types as well as other intravascular devices (IVDs) that allow access to the bloodstream are potential sources of infection, according to research at University of Wisconsin Hospital, Madison. HealthDay News reported on the study, which collected data from more than 200 studies and found that no one device was infection-proof.

A new study in Denmark links healthy teeth and gums with heart health.

Theheart.org reports that Danish investigators have observed an increased risk of coronary heart disease among adults with periodontal disease. In adults 60 years old or younger —with more than 4 mm of alveolar bone loss, as measured by clinical radiography —a significant sixfold increase in the risk of coronary heart disease was documented.

Public confidence in the FDA is low and big changes may be in order to fix the system for approving and regulating drugs, according to a new report by the Institute of Medicine (IOM).

Initiated by the agency itself, the report concludes that Congress, the FDA and the pharmaceutical industry share responsibility for the problems and should bare the burden for developing and implementing solutions.

A new, private research group, the Center for Medical Technology Policy is being formed to provide healthcare clinicians, payers and policymakers with evidence on the effectiveness and safety of emerging surgical procedures, medical devices, diagnostics and biopharmaceuticals, according to a ModernHealthcare.com report.

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