ABBOTT, having recently purchased St. Jude Medical, is already reaping rewards. The FDA has issued MR-conditional labeling for the Assurity MRI pacemaker and the matching Tendril MRI lead. This makes the Assurity MRI concurrently the smallest pacemaker (6mm thick) and one with the longest lifetime (10 years) of any wireless pacemaker that can be safely worn (under certain conditions) inside an MRI scanner up to 1.5 Tesla. This includes full body scanning, so the patients retain their ability to receive imaging for any other condition.
Preparation for scanning is made easy and speedy thanks to a special device that’s placed over the pacemaker, which forces the implant to go into a special MR-safe mode. Once scanning is complete, the pacemaker is reverted the same way back to its normal mode.
The device can regularly upload its performance and patient’s cardiac status data onto the company’s online system from where cardiologists can review it and assess how the therapy is working. This may help reduce the number of trips a patient needs to take to the cardiologist.