Medtronic CONNECT Trial Concludes Enrollment

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 19 May 2008 - 1:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced that patient enrollment in its CONNECTSM trial has concluded. The trial is assessing how the use of the Medtronic CareLink® Network to remotely monitor patients with the 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 Dr. Crossley. "Now that enrollment in the CONNECT trial is complete, we're looking forward to seeing the 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 the 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 the emergency room; and
- Characterizing the 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 the 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 the 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.

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