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First U.S. MRI-Compatible Pacemaker Approved, Though Reimbursement a Challenge

Medtronic has announced the approval of its Revo MRI SureScan magnetic resonance imaging (MRI)-compatible pacemaker, the first pacemaker in the U.S. that is designed specifically for use in an MRI environment. This approval is expected to significantly boost the device market in the coming year due to the roughly 200,000 U.S. pacemaker patients who currently must forego an MRI. The Revo MRI SureScan--which is priced at a comparable level as other pacemakers (ranging from $5,000 to $10,000)--contains two CapSureFix MRI leads and comes with a function that can be turned on before patients receive an MRI to prepare them for the scan. The device, however, is classified as "MR-conditional," meaning that it can be used in an MRI environment only under certain conditions, such as if a patient has never received a lead or pacemaker previously and if an MRI system has a static magnetic field of 1.5 Tesla.


Despite this development, the MRI-compatible pacemaker is expected to face challenges since MRIs for Medicare patients with pacemakers are not currently reimbursable. In 2009, CMS stated that--upon the device's approval--it would be willing to review its data to determine whether it is safe for those with pacemakers to receive MRIs, and whether they would then grant reimbursement for these procedures. As such, experts predict that these pacemakers could receive reimbursement approval as early as March of this year.

Though reimbursement may initially hamper procedures with MRI-compatible pacemakers, this technology advancement will greatly aid patients with pacemakers who require MRIs. This device approval could also boost Medtronic's dominant share of the pacemaker market from 51 percent to up to 61 percent. Boston Scientific and St. Jude are developing MRI-compatible pacemakers as well with the Accent MRI-Compatible Pacer and the Tendtril MRI, signaling an interest from physicians and patients in devices with these capabilities. Moreover, Medtronic is currently implementing a FDA-required post-market study that includes 1,800 patients to further test the device and associated patient outcomes.