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FDA approves 8 cc pacemaker

The FDA has given approval to the Reply family of dual and single-chamber pacemakers from The Sorin Group in Italy. European Union regulators have approved the firm's 8cc device for marketing there.

Reply uses two of the developer’s pacing modes. The modes can switch from one to the other in case of AV block detection, and has been shown to reduce unnecessary pacing. Unnecessary pacing to the right ventricle has been shown to enhance the risk of patients developing heart failure and atrial fibrillation.

The pacemaker in the accompanying photo includes a feature called SmartCheck, which lets the user automate follow-up tests and provide data reporting and recommendations.

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© 2012 Penton Media Inc.


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