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FDA HIGHLIGHTS DEVICES THAT MAKE A DIFFERENCE

November 6, 2006

The FDA recently highlighted a number of devices approved and cleared for marketing by its Office of Device Evaluation in 2005. The agency said it believes the devices "will have a particular impact on patient care."

The highlighted products include:

The ExAblate 2000 system made by InSightec, which uses magnetic resonance image-guided focused ultrasound to target and destroy uterine fibroids;

The DuraSeal Dural sealant system made by Confluent Surgical, used to seal leaks in the dura mater -- the toughest, most fibrous outermost of the three membranes covering the brain and the spinal cord -- during neurosurgical procedures;

The Charité Artificial Disc made by DePuy Spine, the first nonfusion device intended to replace a diseased or damaged intervertebral disc to treat pain associated with degenerative disc disease; and

The SelectSecure Lead Model 3830 made by Medtronic, a surgically implanted wire that connects the heart to an implanted pacemaker.

The full list of devices can be viewed a www.fda.gov/cdrh/annual/fy2005/ode/part1.html (http://www.fda.gov/cdrh/annual/fy2005/ode/part1.html).