WASHINGTON, March 19 (Reuters) - Medtronic Inc's experimental MRI-safe pacemaker should be approved despite limited clinical data as long 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 Dr. 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.
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.
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.
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.
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 Dr. 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.
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.
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.
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.