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Medtronic Begins First-Ever Study to Evaluate New Pacemaker System Designed for Safe Use with MRI Machines.


Advances to Pacemaker and Lead Features Could Enable Hundreds of Thousands of People Worldwide to Get MRI 1. (application) MRI - Magnetic Resonance Imaging.
2. MRI - Measurement Requirements and Interface.
 Scans Even with an Implanted Cardiac Device

MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) today announced the start of an international clinical study to confirm the safety and efficacy of the Medtronic EnRhythm[R] MRI SureScan[TM] pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures.  (MRI) machines under specified scanning conditions. Pacemaker technology has extended the lives of thousands of patients with heart rhythm conditions, and each year nearly one million pacemakers are implanted in patients worldwide. While improvements to pacing technology have continued since its development nearly 50 years ago, this advance marks a concerted effort to pursue compatibility with MRI scans, an important healthcare diagnostic for many conditions.

"For important safety reasons, regulatory agencies worldwide prohibit individuals with implantable cardiac devices from receiving MRI scans," said Steve Mahle, president of the Cardiac Rhythm Disease Management business at Medtronic. "Medtronic has thoroughly researched the risks to patients and designed a pacemaker and lead system from the ground up that we expect will help many, many patients take advantage of the benefits of MRI technology."

The EnRhythm MRI SureScan pacing system consists of the new dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix[R] MRI SureScan[TM] pacing leads (Model 5086MRI). The first clinical trial devices were recently implanted in Europe by Prof. Dr. Firat Duru, University Hospital in Zurich, Switzerland; Dr. Helmut Purerfellner, Elisabethinen Hospital in Linz, Austria; Dr. Gijsbert De Ruiter, Onze Lieve Vrouwe Gasthuis in Amsterdam, The Netherlands; and Dr. Stefan Spitzer, Praxisklinik Herz und Gefasse in Dresden, Germany. The trial, a prospective, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 controlled, unblinded, multi-center study, is planned to occur at hospitals in Austria This is a list of hospitals in Austria. Vienna
  • Vienna General Hospital (Allgemeines Krankenhaus, AKH)
  • Privatklinik Dobling
  • Privatklinik Josephstadt
  • Wiener Privatklinik
  • Steinhof
  • Wilhelminenspital
  • Hanuschkrankenhaus
, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland, United States, and United Kingdom; procedures are expected to begin outside Europe later in the year. Approximately 350 individuals will participate in the study, and eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning.

All patients in the trial will receive an EnRhythm MRI SureScan pacing system, and approximately half of the participants will receive MRI scans; the trial's first MRI scans will occur approximately two to three months after device implant. The study will compare the electrical and diagnostic system performance, as well as complication rates, among patients in both groups. The expected study duration is approximately 24 months.

"We see patients every week who aren't able to get an MRI scan to determine the cause of a clinical issue and must use less effective diagnostic methods because they have a pacemaker," said Prof. Dr. Richard Sutton, cardiologist in the Royal Brompton Hospital The Royal Brompton Hospital, commonly known as The Brompton, is a specialist heart and lung hospital in Brompton, London. It is part of the Royal Brompton and Harefield NHS Trust. It is also the main hospital for allergy testing in London.  in London and European lead cardiology investigator for the EnRhythm MRI SureScan Pacing System Clinical Study. "The ability to perform MRI scans is a critical medical need, especially as the number of people who get medical devices increases; Medtronic's new pacing system is designed to meet this need by enabling pacemaker patients to receive MRI scans."

"MRI safety is an important issue," said Prof. Dr. Torsten Sommer Sommer is a surname, from the German and Danish word for the season "summer".

It may refer to:
  • Alfred Sommer (ophthalmologist) (born 1943), American academic
  • António de Sommer Champalimaud
  • Barbara Sommer (born 1948), German politician (CDU)
, chief of the cardiovascular section of the radiology department, University of Bonn The University of Bonn (German: Rheinische Friedrich-Wilhelms-Universität Bonn) is a public research university located in Bonn, Germany. Founded in 1818 the University of Bonn is nowadays one of the largest universities in Germany. , Germany, and European lead radiology investigator for the clinical trial. "It is critical to protect patients from electromagnetic fields that could contribute to a loss of pacing therapy. The only sure way to do this is to study a pacing system that was designed specifically for use in MRI systems."

The EnRhythm MRI SureScan pacemaker includes modified hardware to minimize the level of energy transmitted through the lead/device connection point. The pacemaker also includes a new SureScan[TM] feature that can be programmed "on" before an MRI scan to eliminate the impact of MRI-generated electrical noise, which can prevent necessary pacing therapy or cause the device to oversense and deliver unnecessary pacing therapy. When the SureScan feature is on, the device's data collection and monitoring functions are temporarily suspended, while allowing the device to continue providing asynchronous Refers to events that are not synchronized, or coordinated, in time. The following are considered asynchronous operations. The interval between transmitting A and B is not the same as between B and C. The ability to initiate a transmission at either end.  pacing if needed. The device and leads also contain radiopaque ra·di·o·paque
adj.
Relatively impenetrable by x-rays or other forms of radiation.


radiopaque (rā´dēōpāk´),
adj
 marks, viewable via X-ray, to indicate that the system is MRI-compatible.

The pacemaker incorporates all diagnostic and therapeutic features of the commercialized Medtronic EnRhythm[R] pacemaker, including an exclusive pacing mode pacing mode Cardiac pacing The manner in which a cardiac pacemaker provides artificial rate and rhythm support during arrhythmias; PMs are ID'd by the NBG Code. See NBG code.  called MVP (Multimedia Video Processor) A high-speed DSP chip from Texas Instruments, introduced in 1994. Officially introduced as the TMS320C80, it combines RISC technology with the functionality of four DSPs on one chip. [TM] or Managed Ventricular Pacing, which enables the device to be programmed to deliver pacing pulses to the right ventricle only when necessary. MVP has been shown to reduce unnecessary right ventricular pacing by 99 percent (median value). Recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient's risk of developing heart failure and atrial fibrillation, a potentially life-threatening irregular heartbeat.

The CapSureFix MRI SureScan leads are modified versions of the active-fixation Medtronic CapSureFix[R] Novus leads, the most-prescribed lead in the history of pacing. Leads are insulated wires that carry precisely timed electrical impulses from the pacemaker in the patient's chest to a specific point on the inner heart wall. Available in three lengths, the atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium.

a·tri·al
adj.
Of or relating to an atrium.


Atrial
Having to do with the upper chambers of the heart.
 and ventricular CapSureFix MRI SureScan leads are designed with modified internal wiring composition to decrease the risk of overheating Overheating

An economy that is growing very quickly, with the risk of high inflation.
 during an MRI scan without limiting the ability to conduct therapy.

About Medtronic

Medtronic, Inc. (www.medtronic.com), 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Feb 9, 2007
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