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New Products In Brief

InSightec, TriVascular and NicOx are among firms with notable recent product approvals or launches.

InSightec Ltd. received PMA approval for its ExAblate magnetic resonance imaging-guided focused ultrasound system to treat pain from bone metastases in patients who do not respond to or cannot undergo radiation treatment for their pain, the company announced Oct. 22. The device relies on high-intensity focused ultrasound energy to thermally ablate nerves while continuous MRI is used to visualize the anatomy. The Israel-based company received its first PMA approval for ExAblate in 2004 as a noninvasive treatment for uterine fibroids. (See Also see "InSightec ExAblate 2000 Approved For Uterine Fibroids; 3-Year Study Required" - Medtech Insight, 25 October, 2004..) FDA based its second approval of the device on an international, multicenter randomized trial that compared patients with painful bone metastases undergoing treatment with ExAblate with a similar cohort undergoing a placebo treatment. InSightec also plans to conduct a multicenter post-marketing study of the device.

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