Medtronic gets FDA panel's support for heart valve

07/22/2009 | Wall Street Journal, The

An FDA advisory panel unanimously voted to back the approval of Medtronic's humanitarian device exemption application for its Melody transcatheter pulmonary valve, which can be implanted to replace the pulmonary valve without requiring patients to undergo open-heart surgery. The panel, however, defined certain conditions for approval, such as requiring the company to conduct postmarket studies and provide a training program for physicians.

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