Medtronic’s Protecta AICDs Make European Debut

Medtronic, having received the CE mark, is bringing to Europe its Protecta line of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds). The devices take advantage of Medtronic’s latest rhythm management algorithms to provide an appropriate amount of shock.

The implantable defibrillators feature Medtronic-exclusive SmartShock™ Technology, comprised of six advanced shock-reduction algorithms that can significantly reduce inappropriate shocks. Findings from the Virtual ICD study statistical model predicted 98 percent of studied patients with SmartShock Technology would be free of inappropriate shocks one year after implant and 92 percent at five years post-implant. These data were presented at Cardiostim 2010, the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques.
New Medtronic data released at Cardiostim from the Managed Ventricular Pacing (MVP) trial show that 24 percent of patients who received painless anti-tachycardia pacing (ATP) to terminate a potentially life-threatening arrhythmia visited the hospital, clinic or emergency room at least once within three days of receiving therapy, versus 56 percent of patients who were treated with appropriate shock therapy, and 61 percent of patients who received an inappropriate shock. This shows shock therapy may correlate with greater health care utilization as compared to ATP.
Additionally, new data released on SmartShock Technology showed lead fracture and T-wave oversensing algorithms can be safely applied without delaying detection of life-threatening arrhythmias.

Three solutions (Wavelet + PR Logic, SVT discrimination in the VF zone, and Confirmation +) in Protecta devices are designed to discriminate between different non-lethal and lethal arrhythmias to provide lifesaving shock therapy only when necessary.

T-wave Discrimination and Lead Noise Discrimination features are designed to distinguish between deadly arrhythmias and oversensing to 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.

Protecta defibrillators have yet to receive FDA approval and are not available in the US.
Press release: Medtronic Announces European Launch of Protecta™ Portfolio with SmartShock™ Technology Shown to Significantly Reduce Inappropriate Shocks…