St. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P). This CRT-P system offers more pacing options to deliver higher success rates, as evidenced by robust clinical data. Allure Quadra CRT-P brings the quadripolar lead technology to the pacemaker market for the first time.
The Allure family of devices also offer enhanced heart failure (HF) diagnostics, including CorVue™ Impedance Monitoring, for improved patient managemen.
“Adding quadripolar technology to the CRT-P platform moves us forward in the treatment of heart failure and allows us to expand the proven clinical benefits to a new patient population,” said Dr Amir Zaidi, Consultant Cardiologist and devices lead at Manchester Royal Infirmary, England. “The new features and additional pacing options allow for optimal lead placement and provide the patient greater opportunities to respond to therapy, while reducing the need for re-intervention.”, he adds.
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 Pacing Trial, 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.
“Since its launch in 2010, the St Jude Medical quadripolar CRT-D platform has allowed physicians to more effectively treat their patients and we expect the same results with our quadripolar CRT-P line,” said Eric S. Fain, M.D., president of the Implantable Electronic Systems Division at St. Jude Medical. “We believe these benefits result in a cost-effective solution that elevates the standard of care for heart failure patients in need of cardiac resynchronization therapy.”
EH News Bureau