Archive for August, 2009

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.

EU approves Zilver PTX drug-coated stent

ZilverAngiotech Pharmaceuticals Inc and Cook Medical’s Zilver PTX drug-coated stent has received approval for use in the European Union (EU). The device is used to prevent blockage of the superficial femoral artery, which is the main blood vessel in the thigh. The use of the stent has already started in patients.

Medtronic wins advisory panel backing for Melody heart valve

MedtronicThe advisory panel for the FDA has backed a new type of heart valve that can be implanted without the open heart surgery required for traditional valves. Medtronic Inc’s Melody heart valve has been recommended for approval for the group of people born with cardiac defects that impede blood flow from the right ventricle to the pulmonary artery. The device can be implanted by threading a tube through a leg vein to the heart.

FDA approves new trauma device

MedtronicPanel recommends Melody Transcatheter Pulmonary Valve
The FDA’s Circulatory System Devices Panel has unanimously recommended the approval of Humanitarian Device Exemption of Medtronic’s Melody Transcatheter Pulmonary Valve. The device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction. The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel.