FDA has cleared Spectranetics’ new line of devices designed to treat clogged leg arteries. The Turbo elite products will be launched in limited release during the fourth quarter, and fully released in early 2007.

The devices are used in conjunction with the company’s excimer laser system, which helps open clogged or obstructed arteries. Spectranetics, Colorado Springs, CO, is a manufacturers of lasers used to treat heart conditions.

CV Therapeutics Inc. says the MERLIN TIMI-36 study of ranolazine will proceed to the study close-out phase now that the required number of endpoints have accumulated, “Medical News Today” reports.

A new procedure that delivers and places or repairs a heart valve through a catheter could soon become an alternative to open heart surgery for extremely high-risk patients.

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.

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