SMART HEART DEVICE approved $38.00 | MDT Message Board Posts


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Msg  42 of 45  at  3/28/2011 5:43:50 PM  by

mlkrborn


SMART HEART DEVICE approved $38.00


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Matthew Perrone, AP Health Writer, On Monday March 28, 2011, 4:47 pm

WASHINGTON (AP) -- Medtronic, the world's largest medical device manufacturer, said Monday that it received federal approval for a new generation of heart defibrillators designed to avoid unnecessary shocks.

The Food and Drug Administration approved the company's Protecta line of implantable heart devices, which use updated programming to monitor the heart and limit therapeutic shocks to life-threatening situations.

Defibrillators are surgically implanted in the upper chest and use electrical jolts to shock the heart back to normal when it beats too fast or gets out of sync. Recent studies show that roughly one in five patients with a defibrillator experience painful, inappropriate shocks.

Medtronic estimates, based on a study, that 92 percent of patients using its new technology will be free of inappropriate shocks five years after implantation.

"The Protecta family of devices addresses one of physicians' top needs -- allowing them to better serve patients by providing devices that are designed to deliver a shock only when needed to save a life," said Pat Mackin, president of Medtronic's heart rhythm unit.

Protecta is one of several new devices that were delayed by an FDA warning letter against Medtronic's Mounds View, Minn.-based facility, stemming from quality control problems found there.

The FDA typically withholds approval of new products when there are outstanding problems at a facility where they would be designed or made. The Mounds View facility is the headquarters of Medtronic's heart products unit, its largest business by sales.

Earlier this month, Medtronic announced that the FDA had lifted the warning letter, which had been in place since Nov. 2009.

The warning letters have been one of several negative factors pressuring the company's stock. The company has also been squeezed by tighter hospital budgets and decreased medical procedures as more American workers lose employer-based health insurance.

Last month, the company announced it would lay off up to 2,000 workers as part of a restructuring effort to make up for anemic sales of its devices.

The company's chief executive, Bill Hawkins, is scheduled to step down in April after three years leading the company.

Shares of Medtronic Inc. rose 49 cents to close Monday at $38.85.


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