FDA approves first MRI Compatible Pacemaker-Europe Had Approval in 2009
Posted Feb 09 2011 1:06pm
The Advisa DR MRI SureScan was approved in June of 2009 in Europe and the new device approved by the FDA is called the Revo MRI SureScan so I might guess with new technologies emerging so quickly this could possibly be an advanced version of what Europe approved.
The FDA did not guarantee blanket coverage for the new unit in stipulating that the use is to be limited to certain patients under specific conditions. Cardiologists and radiologists will require additional training as well. The new device will be more expensive than current models that are not MRI compatible as they run about $5k and the new devices will be somewhere between $8 and $10k. Medicare will cover but again with the stipulations needed with new training and making a case for the extra money it doesn’t appear this will be an easy course to use the new implanted device. BD
The U.S. Food and Drug Administration Tuesday approved a pacemaker compatible with magnetic resonance imaging. The device is the first of its kind in the United States, and will allow patients with pacemakers to safely undergo the exam. The device, called the Revo MRI SureScan pacing system, will begin shipments immediately, according to its developer, Medtronic Inc.