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Medtronic says FDA approves new arrhythmia medical device to U.S. market

Medtronic announced that the FDA has approved Protecta, a new implantable defibrillator line which promises to reduce unnecessary shocks by distinguishing between lethal and non-lethal arrhythmias, thereby reducing inappropriate shocks.

The product launch was previously delayed as the company awaited final resolution of a warning letter from the U.S. Food and Drug Administration. The FDA had previously found problems at Medtronic’s manufacturing facility.

The new innovative medical device reduces unnecessary shocks through what they refer to as “SmartShock Technology,” six algorithms which can distinguish between lethal and non-lethal arrhythmias, as well as electrical noise. Electrophysiologists are able to program the devices for individual patients.

The device is part of Medtronic’s Cardiac and Vascular Group, which accounted for$6.22 billion in sales during the first nine months of the fiscal year. Medtronic’s worldwide net sales had declined due to the delayed launch of the line of defibrillators, but this was offset slightly by Protecta’s growth outside of the United States. Medtronic has high hopes for Protecta, as the reduction of inappropriate shocks was a leading clinical request from physicians.

Medtronic Public Relations Director Wendy Dougherty estimated the size of the market at approximately $6.5 billion worldwide, with the U.S. being about two-thirds (62 percent) of that market.

“Protecta has performed well in certain segments in markets outside the U.S. with positive impact on share and price,” Dougherty said. “Protecta is important to Medtronic’s growth, and we expect to maintain or gain share with Protecta.”

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