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DALLAS, Feb. 21, 2011 /PRNewswire-USNewswire/ — Baylor Jack and Jane Hamilton Heart and Vascular Hospital announced that it implanted the first MRI-safe pacemaker in North Texas last week and the patient has fully recovered.

An interventional cardiologist on the hospital’s medical staff successfully used the Revo MRI™ SureScan^® pacing system, the first MR-Conditional pacing system designed, tested and FDA approved for use in the Magnetic Resonance Imaging (MRI) environment. Prior to the Revo MRI SureScan pacing system, MRI procedures for patients with implanted pacemakers were not recommended because these patients might face serious complications, such as interference with pacemaker operation, damage to system components, lead or pacemaker dislodgement or change in pacing capture threshold.

The number of patients with pacemakers is growing at the same time that the use of MRI is increasing. About 40 million MRI scans are performed annually in the United States. MRI is often preferred by physicians because it provides a level of detail and clarity not offered by other soft tissue imaging modalities.

It has been estimated that there is a 50 to 75 percent probability that cardiac device patients will be indicated for an MRI over the lifetime of their devices. Furthermore, more than 200,000 patients annually in the U.S. have to forego an MRI scan because they have a pacemaker(i). The Revo MRI SureScan pacing system can help address this important unmet patient need.

Developed by Medtronic, the Revo MRI SureScan pacing system is the first pacing system of its kind in the U.S. The Revo MRI SureScan pacing system was designed to address safety concerns around MRI procedures for patients who have implanted pacemakers. MRI scanners may cause traditional pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy. The Revo MRI pacing system, when programmed into SureScan mode prior to an MRI scan, is designed to be used safely in the MRI environment.

“Medical imaging and electronic implantable devices such as pacemakers are important technological advances, particularly for older people,” said Nancy Vish, RN, Ph.D., Baylor Hamilton’s president. “Baylor Hamilton Heart and Vascular Hospital is proud to provide safer access to MRI for our patients. We encourage our patients to talk to their doctor about which pacing system is right for them.”

A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSure Fix MRI™ SureScan leads is required for use in the MRI environment.  Any other combination may result in a hazard to the patient during an MRI scan.  The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use.  Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient.  Consult Medtronic’s website at www.medtronic.com.

Newly-OK’d device paves way for thousands of heart patients to get MRI diagnostic scans

SCOTTSDALE, Ariz., Feb. 17, 2011 /PRNewswire-USNewswire/ — Scottsdale Healthcare Shea Medical Center is the first hospital in the southwestern United States to implant an MRI-safe pacemaker, a major technological breakthrough for patients who need MRI diagnostic scans, which can damage older style pacemakers or cause serious health complications.

A pacemaker is a small device placed in the chest to help control abnormal heart rhythms, using electrical pulses to prompt the heart to beat at a normal rate. Some 200,000 pacemaker patients in the United States annually are not eligible for MRI scans, which are critical for making a wide range of health diagnoses.

Up to 75% of patients with electronic cardiac devices will likely need an MRI over their device’s lifetime, according to pacemaker manufacturer Medtronic, Inc. of Minneapolis.

The MRI-safe pacemaker was implanted by Scottsdale Healthcare  electrophysiologist Dr. Thomas Mattioni, who successfully placed the device in an 81-year-old patient at Scottsdale Healthcare Shea Medical Center. The Medtronic Revo MRI SureScan heart pacemaker received approval from the U.S. Food and Drug Administration on Feb. 8.

“MRI-safe pacemakers allow improved detection and treatment of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopedic conditions,” said Dr. Mattioni. Previously, these patients either did not get an MRI, or were exposed to higher radiation CT scans, he said.

Magnetic Resonance Imaging exposure can interfere with pacemaker operation, damage the device or change the pacing capture threshold, the minimum amount of electrical current required to evoke a cardiac contraction.

Dr. Mattioni said that prior to the introduction of the MRI-safe pacemaker, patients could face serious complications if exposed to the powerful magnetic fields generated by MRI machines, which can be as much as 30,000 times more powerful than the Earth’s magnetic field.

“Patients at Scottsdale Healthcare now have access to a state-of-the-art pacemaker that is designed to work safely and effectively in an MRI environment,” said Dr. Mattioni,  medical director of Electrophysiology at Scottsdale Healthcare. . “This new pacemaker technology can provide a meaningful difference in patients’ lives.”

Pacemaker use is growing, with approximately five million patients worldwide who currently are implanted with a pacemaker or implantable cardioverter-defibrillator.

At the same time, use of MRI as a diagnostic tool is increasing, with approximately 30 million scans completed in 2007. Individuals over age 65 are twice as likely to need an MRI compared with younger patients.

The Revo MRI pacemaker is considered MR-Conditional, a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings.

MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy. This new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment. This new pacing system also includes specially designed leads (insulated wires that are placed into the heart) which protect the patient from heart damage that can occur if MRI is performed in currently available pacing systems.

Scottsdale Healthcare  is the largest employer in Scottsdale and the community-based, nonprofit parent organization of the Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital, Virginia G. Piper Cancer Center at Scottsdale Healthcare and Scottsdale Healthcare Research Institute

SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI’s  magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.”

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.