Medtronic Gains FDA Approval for New Protecta™ Line of ICDs
The medical equipment manufacturer Medtronic, maker of defibrillators for patients with irregular heartbeats, has recently released a new line of implantable defibrillators in its Protecta™ line. Recently approved by the US Food and Drug Administration, these devices are designed to recognize an irregular heartbeat that may be life-threatening, and only deliver a therapeutic shock when it is appropriate. The need for implanted defibrillators that limit inappropriate shocks became apparent when patients started complaining about certain devices that delivered an ill-timed shock when it wasn’t needed.
Electrical noise or a non-life threatening arrhythmia should not prompt an implanted defibrillator to produce a shock to the heart; it should only be used to bring a ventricular arrhythmia back to its normal beating rhythm. Despite this fact, up to 21 percent of patients with an implanted defibrillator had experienced these inappropriate shocks. Throughout clinical testing of the Medtronic Protecta™ devices, 98 percent of patients were free of inappropriate shocks and stayed free of them after a full year with the implant.
Known as implantable cardioverter-defibrillators, or ICDs, the Protecta™ XT uses SmartShock technology to prevent the occurrence of inappropriate shocks. These unneeded shocks can not only be dangerous, they can also cause pain and anxiety, or lead patients to cut back on their normal life activities. Recent research even suggests that minimizing these shocks could improve the survival rate of ICD patients.
Medtronic will present the results of the virtual ICD study at upcoming medical equipment conferences for cardiology, which show the effectiveness of the six algorithms used in the SmartShock® device. These algorithms were developed to help the ICD discriminate between life-threatening and non-life threatening arrhythmic events.
In addition to SmartShock, the Protecta™ XT includes a new technology called OptiVol® 2.0. This fluid status monitoring device is designed to help doctors accurately predict worsening heart failure and identify higher risk patients.






