Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology

 News Release - December 11, 2006

Medtronic CONNECT Trial to Examine Role of Remote Patient Monitoring System in Improving Patient Care and Reducing Healthcare Costs

Largest Nationwide Study Will Further Define Clinical and Financial Benefits of Implantable Cardiac Devices with Wireless Remote Monitoring Capabilities

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic Inc. (NYSE:MDT ) today announced the start of its CONNECT(SM) trial, which will further substantiate the impact of Medtronic's most advanced devices with Conexus(TM) Wireless Telemetry remote monitoring capabilities. The trial will assess how effectively the use of the Medtronic CareLink® Network to remotely monitor patients with the Concerto(TM) Cardiac Resynchronization Therapy-defibrillator (CRT-D) and Virtuoso(TM) implantable cardioverter-defibrillator (ICD) enables better patient care and reduces unnecessary healthcare costs.

"We expect the data collected in the CONNECT study will show that by making clinical decisions earlier based on our remote patient monitoring system, healthcare utilization costs can be shifted away from more acute - and costly - interventions," said Steve Mahle, president of the Cardiac Rhythm Disease Management business at Medtronic. "Earlier interventions such as medication adjustments and device programming changes may prevent patients' disease from progressing to the point where they require acute, high-cost treatment."

He added, "Healthcare costs in this country continue to climb at extraordinary rates, and we expect this study will support the idea that earlier care results in reduced overall costs to the healthcare system and provides significantly better health outcomes for patients."

First implants in the trial were recently performed by Dr. Marc Silver of Raleigh Cardiology, Raleigh, N.C. The principal investigator in the CONNECT trial is Dr. George Crossley, chief of electrophysiology at Baptist Hospital and Mid-State Cardiology in Nashville, Tenn.

"We hope to validate through this research that the use of wireless remote monitoring enables earlier intervention, and therefore better, safer, more efficient patient care," said Dr. Crossley. "The devices used in this study offer insights into patients' disease states, in addition to the status of their defibrillator, providing us with a full spectrum of diagnostic and clinically useful data. For example, we can be notified via a CareAlert if a patient experiences a sustained bout of atrial fibrillation, a dangerous quivering of the heart that can lead to stroke and heart failure. With this prompt notification, we can intervene before the patient's condition worsens."

About the CONNECT Trial:

CONNECT, or Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision, is a randomized, prospective study that will include 2,000 patients at 150 centers across the United States. The primary endpoint 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.

About the Medtronic Remote Monitoring System:

Medtronic has developed a comprehensive remote patient monitoring system, comprised of the Concerto CRT-D device, Virtuoso ICD devices, Conexus Wireless Telemetry with SmartRadio(TM) Technology, CareAlerts(TM), and the Medtronic CareLink Monitor and Network.

The Concerto CRT-D and Virtuoso ICD utilized in this trial are the first implantable cardiac devices available with Medtronic's proprietary Conexus Wireless Telemetry with SmartRadio Technology, developed using the Medical Implant Communications Service (MICS, 402-405 MHz). Using the SmartRadio Technology in the MICS band enables reliable communication between the implanted device and clinician programmers and patient home monitoring units.

Conexus Telemetry provides efficiencies at device implant, during in-office follow-up visits, and at home. At implant, there is no need for the programming head to enter the sterile implant field, and in-office visits (when needed) may be simplified by interrogating patients' devices via wireless telemetry without the need for a programming head. In addition, the clinician can obtain an ECG without the need for surface electrodes.

At home, Conexus Telemetry enables two-way, automatic, wireless data transmission from the patient's device and a bedside monitor. Device data is transmitted to the clinician using the Medtronic CareLink Monitor and Network, which connects physicians and patients to better manage chronic cardiovascular disease treated by implantable device therapy. Communication between device and monitor is initiated when the device detects an alert that the physician has programmed for automatic notification. If the system detects notable changes in the patient's condition or device status, a Medtronic CareAlert will be sent to the physician, providing the potential for treatment decisions before the condition worsens. Communication between the device and monitor also can occur on scheduled dates that are preprogrammed via the Medtronic CareLink Network.

The Medtronic CareLink Network has been the leading Internet-based remote patient monitoring system since its introduction in 2002. Today, nearly 95,000 patients at more than 1,000 clinics in the United States are followed remotely, saving patients time by eliminating in-office visits, and allowing physicians to perform a complete analysis of all the device- and patient-specific cardiac data stored within Medtronic patients' ICDs, pacemakers and CRT devices.

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.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.

Source: Medtronic

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.