February 13th, 2013
FDA Approves Second-Generation MRI-Friendly Pacemaker System from Medtronic
Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next-generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads.
Medtronic said that more than 100,000 of its first-generation Revo SureScan devices have been sold worldwide and that more than 10% of patients who have received the device have had an MRI.
When first proposed, the prospect of MRI-friendly pacemakers was greeted with considerable interest and enthusiasm. Since then, however, the devices have not lived up to initial expectations, in part because of the lack of evidence showing any danger with previous devices. According to electrophysiologist Wes Fisher, however, CMS will not pay for an MRI for patients with devices that have not been tested and approved for use with MRI. (Click here for the CMS decision memo.)
According to Medtronic, the Advisa system contains several significant new features, including these:
- a complete capture-management system, leading to improved battery life,
- higher upper tracking rates, which will allow quicker heart rates for people exercising, and
- rate-drop response to reduce syncope.
The two Medtronic devices are the only FDA-approved MRI-friendly pacemaker systems in the U.S. According to Fierce Medical Devices, St. Jude Medical and Biotronik are developing MRI-friendly pacemakers for the U.S. market.