[caption id="attachment_31225" align="alignleft" width="324" caption="Dr. Peter Chang-Sing"][/caption]
SANTA ROSA -- Santa Rosa Memorial Hospital last week implanted an MRI-safe pacemaker into a patient, making it the first hospital north of the Golden Gate Bridge to do so, according to the hospital and the medical device maker.
Minneapolis-based Medtronic, whose cardiovascular division is based in Santa Rosa, created the Revo MRI SureScan pacing system, which the company said is the only pacemaker in the country designed for use in an MRI environment.
The new technology allows pacemaker patients to safely undergo a fairly common procedure that is typically bypassed because of potential complications,
"For many of our patients, as medicine advances and they live longer, they're going to need an MRI to diagnose health-related problems," said Dr. Peter Chang-Sing, the implanting physician and medical director for Electrophysiology Services at Memorial's Heart and Vascular Institute.
"Now we have a device which allows these patients to take advantage of the MRI's diagnostic capabilities and its lower risk of radiation exposure compared to others imaging tests."
An estimated 200,000 pacemaker recipients in the U.S. must forgo MRI scans due to "serious complications" that can arise when the cardiac device is subjected to the powerful magnetic field used in MRIs, or magnetic resonance imaging, according to Medtronic.
Patients with traditional pacemakers are exposed to significant risks when undergoing MRIs, including unintended cardiac stimulation, overheating of the pacemaker's leads and resulting injury to the patient's heart, and a malfunctioning pacemaker, the level II trauma center said in announcing the implementation.
Medtronic received approval from the Food and Drug Administration in February for the MRI-friendly pacemaker.
Dr. Chang-Sing said 80 percent of new pacemaker patients would likely opt for the MRI-compatible device, because of prospective health needs or future needs for MRI testing.
About 1.5 million people currently have pacemakers, according to Medtronic.
The new pacemaker costs between $5,000 and $10,000, on par with existing pacemakers, according to Medtronic.
Medicare has never covered MRIs for pacemaker patients. Despite Medtronic getting FDA approval on the Revo system, Medicare will continue its policy to not cover any scans. The center for Medicare and Medicaid Services issued a memorandum in late February saying it would not cover MRI scans, after a physician lobbied them to do so.
Medtronic is asking the agency to again reconsider the policy.