By Susan Heavey
COLLEGE PARK, Md., March 19 (Reuters) - Medtronic Inc's experimental MRI-safe pacemaker should be approved despite limited clinical data as long as further study is done, U.S. health advisers unanimously said on Friday.
The Food and Drug Administration's panel of outside experts said the company's Revo MRI SureScan Pacing System was an important development for patients who need to undergo MRI tests for other conditions.
'I think that the device has important clinical uses' despite the 'residual uncertainty' from some of the data analyses, said panelist Michael Domanski of the National Institutes of Health's heart institute.
Medtronic is seeking approval of the device as a safe alternative that allows patients to safely undergo magnetic resonance imaging (MRI) scans that otherwise can interfere with the heart devices and be dangerous.
Unlike other imaging tests, magnets used in MRIs can disrupt the pacemaker and cause unintended shocks, heated wires and other problems.
Medtronic officials told the FDA's panelists that its device was a significant technological milestone that could help more patients get necessary testing for other conditions, especially as such scans become more commonplace.
'There's a growing need for pacemaker patients to have safe access to MRI,' said David Steinhaus, a Medtronic vice president.
Nearly 30 million MRI scans are conducted in the United States each year, according to the FDA, and at least half of all patients with implanted cardiac devices will develop conditions that call for the test.
FDA staff at the meeting pointed to several limitations with the company's data. Studies were not large enough to draw 'meaningful conclusions,' and they were not designed to look at the effect of multiple MRI scans in patients, staffers said.
But panel member David Naftel of the University of Alabama echoed others who said it would have been extremely difficult for the company to have conducted a larger trial with more patients given the complexity and technology involved.
'If there were three times this many patients in the study, I'm not sure we would have learned more,' he said of the study's roughly 460 patients. 'The results are good.'
Medtronic said if it wins approval it would continue to study the device with a 5-year postmarketing study of 1,800 patients. FDA panelists said such a study should be required by the agency as part of approval and that the trial should focus on the effect of multiple MRI scans, among other issues.
Panelists also said product labeling must clearly state the pacemaker is only safe for use with the scans when implanted with Medtronic's accompanying SureScan wire, also known as a lead.
After the meeting, Pat Mackin, president of the Medtronic unit that includes pacemakers, said the device could ultimately become a market-leader as providers opt for an MRI-safe version just in case their patients need the scans later on.
'I think this will eventually become the standard of care,' he said.
Agency officials will weigh the advisory panel's recommendation. Medtronic spokeswoman Wendy Dougherty said it expects the FDA to make a decision in the first half of the company's fiscal 2011.
The device maker's shares closed at $44.79 on the New York Stock Exchange, down 38 cents, but were up slightly at $45 in after hours trading.
(Reporting by Susan Heavey; editing by Andre Grenon) Keywords: MEDTRONIC PACEMAKER/ (sheavey@thomsonreuters.com +1 202 354 5848; www.twitter.com/ReutersDChealth) 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.
COLLEGE PARK, Md., March 19 (Reuters) - Medtronic Inc's experimental MRI-safe pacemaker should be approved despite limited clinical data as long as further study is done, U.S. health advisers unanimously said on Friday.
The Food and Drug Administration's panel of outside experts said the company's Revo MRI SureScan Pacing System was an important development for patients who need to undergo MRI tests for other conditions.
'I think that the device has important clinical uses' despite the 'residual uncertainty' from some of the data analyses, said panelist Michael Domanski of the National Institutes of Health's heart institute.
Medtronic is seeking approval of the device as a safe alternative that allows patients to safely undergo magnetic resonance imaging (MRI) scans that otherwise can interfere with the heart devices and be dangerous.
Unlike other imaging tests, magnets used in MRIs can disrupt the pacemaker and cause unintended shocks, heated wires and other problems.
Medtronic officials told the FDA's panelists that its device was a significant technological milestone that could help more patients get necessary testing for other conditions, especially as such scans become more commonplace.
'There's a growing need for pacemaker patients to have safe access to MRI,' said David Steinhaus, a Medtronic vice president.
Nearly 30 million MRI scans are conducted in the United States each year, according to the FDA, and at least half of all patients with implanted cardiac devices will develop conditions that call for the test.
FDA staff at the meeting pointed to several limitations with the company's data. Studies were not large enough to draw 'meaningful conclusions,' and they were not designed to look at the effect of multiple MRI scans in patients, staffers said.
But panel member David Naftel of the University of Alabama echoed others who said it would have been extremely difficult for the company to have conducted a larger trial with more patients given the complexity and technology involved.
'If there were three times this many patients in the study, I'm not sure we would have learned more,' he said of the study's roughly 460 patients. 'The results are good.'
Medtronic said if it wins approval it would continue to study the device with a 5-year postmarketing study of 1,800 patients. FDA panelists said such a study should be required by the agency as part of approval and that the trial should focus on the effect of multiple MRI scans, among other issues.
Panelists also said product labeling must clearly state the pacemaker is only safe for use with the scans when implanted with Medtronic's accompanying SureScan wire, also known as a lead.
After the meeting, Pat Mackin, president of the Medtronic unit that includes pacemakers, said the device could ultimately become a market-leader as providers opt for an MRI-safe version just in case their patients need the scans later on.
'I think this will eventually become the standard of care,' he said.
Agency officials will weigh the advisory panel's recommendation. Medtronic spokeswoman Wendy Dougherty said it expects the FDA to make a decision in the first half of the company's fiscal 2011.
The device maker's shares closed at $44.79 on the New York Stock Exchange, down 38 cents, but were up slightly at $45 in after hours trading.
(Reporting by Susan Heavey; editing by Andre Grenon) Keywords: MEDTRONIC PACEMAKER/ (sheavey@thomsonreuters.com +1 202 354 5848; www.twitter.com/ReutersDChealth) 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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