Medtronic CONNECT Trial Concludes Enrollment |
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Medtronic CONNECT Trial Concludes Enrollment![]() Medtronic, Inc. ( NYSE: MDT ) announced that patient enrollment in its CONNECTSM trial has concluded. The trial is assessing how the use of Medtronic CareLink Network to remotely monitor patients with Concerto cardiac resynchronization therapy-defibrillator ( CRT-D ) and Virtuoso implantable cardioverter-defibrillator ( ICD ) effectively enables better patient care and reduces unnecessary healthcare costs. Principal investigator is George Crossley, M. D. , chief of electrophysiology at Baptist Hospital and Mid-State Cardiology in Nashville, Tenn. " Timely patient information delivered by wireless remote monitoring and CareAlert™ notifications is critical for physicians to effectively manage patients' cardiac conditions, " said Doctor Crossley. " Now that enrollment in the CONNECT trial is complete, we are looking forward to seeing data, which we believe will bear out that early indication of worsening heart conditions leads to early interventions, preventing costly hospitalizations. " CONNECT ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision ) is a randomized, prospective study that includes 2, 000 patients at 141 centers across United States; patients will be followed for 15 months. The primary objective is to: - Demonstrate that Medtronic's wireless remote management system reduces the time to clinical decision for arrhythmias ( abnormal heart rhythms ) , cardiovascular disease progression, and system issues compared to patients who receive only in-office care. Secondary objectives include: - A reduction in healthcare utilization, such as hospitalizations and visits to emergency room; and - Characterizing burden of in-office follow up visits for patients and their families, among other patient quality of life issues. " Naturally, we'd expect that making clinical decisions earlier will help shift healthcare costs away from acute - and therefore more costly - interventions, " said David M. Steinhaus, M. D. , vice president and medical director of Cardiac Rhythm Disease Management business at Medtronic. " If physicians can receive early notification of condition changes through remote monitoring, they can adjust medications or change implanted device settings that may prevent disease progression to point where patients require action in an emergency department or other hospitalization. " About Medtronic Medtronic, Inc. , headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic Explore health advises and choose right way. |
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Medtronic CONNECT Trial Concludes Enrollment Relpax? For what? FDA approved Relpax FDA 101: Product Recalls - From First Alert to Effectiveness Checks. Here's a look at FDA involvement in product recalls from the moment the agency is notified to successful completion of the recall. Explore health advises and choose right way. |