FDA HIGHLIGHTS DEVICES THAT MAKE A DIFFERENCE
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).