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St. Jude launches first U.S. trial of its renal denervation system. Universal decolonization reduces ICU infections better than screening-based approaches. More research news.

FDA has granted St. Jude Medical Inc. an investigational device exemption for the EnligHTN IV trial, the first U.S. trial using the EnligHTN multielectrode renal denervation system, the company announced June 4. EnligHTN IV is the pivotal U.S. trial that will be the basis for an eventual FDA application for the EnligHTN renal denervation system for treating drug-resistant hypertension. (See Also see "St. Jude Plans Trial To Study Renal Denervation Outcomes" - Medtech Insight, 25 February, 2013..)

The randomized, single-blind study is planned for 590 patients with blood pressure of at least 160 mmHg who are taking...

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