FDAnews
www.fdanews.com/articles/75612-fda-approves-guidant-s-new-crt-d-wireless-system

FDA APPROVES GUIDANT'S NEW CRT-D, WIRELESS SYSTEM

August 22, 2005

Medical devicemaker Guidant said the FDA has approved a new implantable defibrillator and a wireless system that can program how the device treats patients.

Guidant's Contak Renewal 3 RF is the company's first wandless cardiac resynchronization therapy defibrillator (CRT-D). When used with the new Zoom Latitude wireless programmer, physicians can take noninvasive readings on the implanted device and adjust therapy without the use of a wand. Guidant said the wireless system will save physicians and patients time during implant and at follow-up, with device interrogations that can be three times faster than Guidant's previous programmer.

Guidant plans to introduce these products in the U.S. during the fourth quarter of this year.

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