WASHINGTON, March 16 (Reuters) - A Medtronic Inc study meant to back a proposed MRI-safe pacemaker has several key limitations, U.S. device reviewers said in documents released on Tuesday.
The study of the Revo MRI SureScan Pacing System was modest in size, and a substantial amount of data was missing, Food and Drug Administration staff said.
The reviewers said they would ask an advisory panel if Medtronic's data support the safety and effectiveness of the device, which is designed to be safe for patients undergoing magnetic resonance imaging scans.
The panel is scheduled to meet Friday.
Medtronic shares fell 1.5 percent to $45.12 on the New York Stock Exchange.
(Reporting by Lisa Richwine; Editing by Lisa Von Ahn) Keywords: MEDTRONIC PACEMAKER/ (lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The study of the Revo MRI SureScan Pacing System was modest in size, and a substantial amount of data was missing, Food and Drug Administration staff said.
The reviewers said they would ask an advisory panel if Medtronic's data support the safety and effectiveness of the device, which is designed to be safe for patients undergoing magnetic resonance imaging scans.
The panel is scheduled to meet Friday.
Medtronic shares fell 1.5 percent to $45.12 on the New York Stock Exchange.
(Reporting by Lisa Richwine; Editing by Lisa Von Ahn) Keywords: MEDTRONIC PACEMAKER/ (lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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