Medtronic Protecta Implantable Cardiac Devices Win US Clearance

Medtronic has received FDA approval for its Protecta line of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).

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

• Wavelet + PR Logic, SVT discrimination in the VF zone, and Confirmation + in Protecta devices are designed to detect non-lethal arrhythmias and deliver lifesaving shock therapy only when necessary.

• T-wave Discrimination and Lead Noise Discrimination distinguish oversensing from deadly arrhythmias and withhold shock therapy when appropriate.

• Lead Integrity Alert, first released in 2008, provides advanced warning of potential lead fractures so the patient can seek medical attention, and reduces the risk of receiving an inappropriate shock.

All Protecta XT devices have OptiVol® 2.0 Fluid Status Monitoring, a new update on the Medtronic-exclusive feature that measures changes in fluid build-up in heart failure patients to identify patients at risk of worsening heart failure. Medtronic implantable defibrillators have Conexus® Wireless Telemetry that allows patients to transmit device data to a physician’s clinic from virtually anywhere via the industry’s largest remote monitoring system, the Medtronic CareLink® Network. CareLink serves more than 4,000 clinics and 500,000 patients in 30 countries.