SmartShock: FDA approves Medtronic's implantable defibrillator

The new heart devices recognize when a fast or irregular beat becomes life-threatening and deliver shock only when appropriate.

A new family of heart devices recognizes when a fast or irregular beat becomes life-threatening and delivers shock only when appropriate.

This SmartShock Technology is found in Medtronic's new implantable defibrillators – known as Protecta – and they were approved by the US Food and Drug Administration yesterday.

Implantable defibrillators provide electrical jolts to return fast or irregular heartbeats to their normal pace. These ventricular arrhythmias can lead to sudden cardiac death – more than 70,000 lives have been saved worldwide by the shock of these devices, Medtronic estimates.

But recent studies show that one in 5 patients may experience inappropriate shocks – mostly caused by benign arrhythmia or electrical noise sensed by the device. About 61% of these patients had to seek medical care within 3 days.

According to Medtronic, 98% of patients with the new technology will be “free of inappropriate shocks” one year after implantation and 92% will be inappropriate-shock-free for 5 years.

The approval of Protecta – as well as that of Medtronic's MRI-safe pacemaker – had been delayed by warning letters the FDA issued in Nov. 2009 because of problems found at its facility in Mounds View, Minn. The site is the company's headquarters for heart-rhythm devices, their largest business by sales [AP]. Medtronic resolved the warning letters earlier this month. Shipment begins immediately.

The company has supported 8 major shock reduction clinical trials (Shock-Less, PREPARE, PainFree Rx I and II, PainFree SST, WAVE, ADVANCE III and EMPIRIC) including more than 5,500 patients worldwide.

Image: Medtronic

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