Medtronic Protecta defibrillators receive FDA approval

The US Food and Drug Administration (FDA) has approved Medtronic’s Protecta portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).

Medtronic said the new family of implantable defibrillators features SmartShock Technology, which includes six new Medtronic-exclusive algorithms that recognize life-threatening arrhythmias and deliver therapeutic shocks only when appropriate.

Findings from the Virtual ICD study, based on a statistical model, shows that 98% of patients with SmartShock Technology will be free of inappropriate shocks one year after implant and 92% will be free of inappropriate shocks five years after implant.

Medtronic president of the Cardiac Rhythm Disease Management business and senior vice president Pat Mackin said 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.

Medtronic has supported eight major shock reduction clinical trials (Shock-Less, PREPARE, PainFree Rx I and II, PainFree SST, WAVE, ADVANCE III and EMPIRIC).