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Medtronic heart devices approved

The US Food and Drug Administration has approved a new family of implantable cardiac devices from Medtronic that are intended to reduce the number of inappropriate therapeutic shocks that are delivered

The US Food and Drug Administration has approved a new family of implantable cardiac devices from Medtronic that are intended to improve patients' quality of life by significantly reducing the number of inappropriate therapeutic shocks that are delivered.

The new Protecta portfolio of products, which will begin shipments immediately, includes implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy-defibrillators (CRT-Ds) that use the company's SmartShock Technology, which is based on six algorithms that recognise life-threatening arrhythmias and deliver therapeutic shocks only when appropriate.

A virtual study conducted by Medtronic based on a statistical model found that the technology results in 98 per cent of patients being free of inappropriate shocks one year after implant and 92 per cent being free of inappropriate shocks five years after implant.

Currently, up to one in five patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device, according to the company.

29th March 2011

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