FDA clears Medtronic MR-Conditional pacemaker

13 February 2013 (Last Updated February 13th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved Medtronic's new MR-Conditional pacemaker for use with MRI scanners.

MEDTRONIC

The US Food and Drug Administration (FDA) has approved Medtronic's new MR-Conditional pacemaker for use with MRI scanners.

The Advisa DR MRI SureScan pacing system has been designed to be compatable with MRI scanners in the US.

During the company's Advisa MRI clinical trial, none out of 156 patients scanned showed any MRI-related complications.

Cardiology Associates of East Tennessee medical doctor Dr Rod Gimbel said; "With more than 85 percent of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it's key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure."

The pacing system, which offers complete automaticity with ventricular and atrial capture management, eliminates manual threshold checks and extends longevity of the device by up to one year.

The system also features diagnostics tools such as the Cardiac Compass Report and atrial fibrillation management.

Diagnostic device and comprehensive arrhythmia data can be transmitted to a physician's clinic by remote monitoring of the patient via Medtronic's CareLink Network, according to the company.

The Rate Drop Response feature also identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may reduce the frequency of syncope (fainting) in patients with apparent cardio-inhibitory vasovagal syncope.

In addition, the system features a high upper tracking rate to provide pacing support at higher heart rates for active and younger patients.


Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.