St. Jude Medical won the CE Mark and is releasing its Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P) in Europe. This is the first device of its kind to use quadripolar leads, although St. Jude has previously implemented them in cardiac resynchronization therapy defibrillator (CRT-D) devices (see flashbacks below).
The additional electric potential poles allow for greater control of therapy when programming the device and reduce the potential need for repositioning the leads since there are twice as many contact points.
The Allure family of devices also offer enhanced heart failure (HF) diagnostics, including CorVue™ Impedance Monitoring, for improved patient management.
The new platform of St. Jude Medical low-voltage devices includes the only CE Mark approved algorithm for identifying stroke risk. The ASSERT, or ASymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial PacingTrial, was designed to determine whether the detection of arrhythmias using pacemaker-based diagnostics predicts an increased risk of stroke in elderly, hypertensive patients without any history of atrial fibrillation (AF). Results found that pacemaker patients who have no history of atrial tachycardia (AT) or atrial fibrillation (AF), but have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.
Additionally, the Allure CRT-P device improves HF management with timely access to vital diagnostic data including CorVue™ Impedance Monitoring for earlier insight into HF progression, and Direct Trend™ Reports for a simplified look at all device data. The Allure Quadra CRT-P integrates the best-in-class quadripolar technology with multiple pacing configurations and TailoredTherapy™ features designed to enable physicians to address the dynamic challenges of HF by optimizing the quadripolar system at implant and follow-up.