Testing more drug-eluting stents

Abbott Vascular Devices, Abbott Park, Ill, (abbottvascular.com) received conditional approval from the FDA on its Investigational Device Exemption (IDE) application for the ZoMaxx drug-eluting stent. As a result, the company will soon begin enrolling the first 250 of 1,670 patients. The trial will include coronary artery disease patients in up to 80 centers and compare clinical outcomes in patients who are treated with Abbott's investigational ZoMaxx drug-eluting coronary stent with patients who receive Boston Scientific's Taxus Express2 drug-eluting stent.

Automate quality-control management

The FDA recently issued the draft guidance, Quality Systems Approach to Current Good Manufacturing Practices (CGMP). To address this guidance, Document Control Systems, Salt Lake City, released a complementary white paper that presents the benefits of using today's technology to automate electronic change control and change-management systems. Get the white paper at mastercontrol.com/advertising/bmn/change_control.html

Defibrillator can be used on children

Royal Philips Electronics, Andover, Mass., received FDA clearance of the Philips HeartStart FRx Defibrillator. The automated external defibrillator (AED) is targeted at those who first get to a victim of sudden cardiac arrest and is easy enough to be used successfully by responders who have minimal AED training. The defibrillator differentiates itself from others by having wireless data transfer, and an infant or child key that automatically reduces shock energy.