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, U.S. Food and Drug Administration staff said ahead of a public advisory meeting on Friday.
'FDA views the study design as one intended to be confirmatory to more comprehensive preclinical testing,' agency reviewers said in a summary prepared for the panel.
The reviewers said they would ask the 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 to diagnose health problems.
Medtronic shares fell 1.5 percent to $45.12 on the New York Stock Exchange.
The company is seeking FDA approval to market the device in the United States under certain scanning conditions. MRIs are known to interfere with pacemakers and can cause them to stop working or send irregular electronic pulses.
Medtronic spokesman Christopher Garland said the company worked closely with the FDA on its study design and 'absolutely supplied all of the data that was required in the predefined protocol.'
The company's findings 'provide ample data to demonstrate the safety and efficacy' of the product, Garland said.
Medtronic expects to launch the product in the second half of this year if it wins FDA approval, he added.
The advisory panel scheduled to meet on Friday will decide whether to recommend approval. The FDA will make the final ruling but usually follows panel recommendations.
A similar SureScan pacemaker was approved in Europe in 2008, according to Medtronic.
(Reporting by Lisa Richwine, Susan Heavey and Susan Kelly; Editing by Lisa Von Ahn and Richard Chang) 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, U.S. Food and Drug Administration staff said ahead of a public advisory meeting on Friday.
'FDA views the study design as one intended to be confirmatory to more comprehensive preclinical testing,' agency reviewers said in a summary prepared for the panel.
The reviewers said they would ask the 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 to diagnose health problems.
Medtronic shares fell 1.5 percent to $45.12 on the New York Stock Exchange.
The company is seeking FDA approval to market the device in the United States under certain scanning conditions. MRIs are known to interfere with pacemakers and can cause them to stop working or send irregular electronic pulses.
Medtronic spokesman Christopher Garland said the company worked closely with the FDA on its study design and 'absolutely supplied all of the data that was required in the predefined protocol.'
The company's findings 'provide ample data to demonstrate the safety and efficacy' of the product, Garland said.
Medtronic expects to launch the product in the second half of this year if it wins FDA approval, he added.
The advisory panel scheduled to meet on Friday will decide whether to recommend approval. The FDA will make the final ruling but usually follows panel recommendations.
A similar SureScan pacemaker was approved in Europe in 2008, according to Medtronic.
(Reporting by Lisa Richwine, Susan Heavey and Susan Kelly; Editing by Lisa Von Ahn and Richard Chang) 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.
