The FDA granted Medtronic Inc. (NYSE:MDT) the go-ahead on a clinical trial to test its next generation of MRI pacemaker technology, the company announced today.
The Minneapolis, Minn.-based med-tech giant can enroll up to 250 patients in 50 medical centers across Europe, Central Asia, the U.S., Canada and Australia to test its new Advisa SureScan pacing system, Medtronic spokeswoman Wendy Dougherty said.
Advisa represents an improvement on the Revo, Medtronic’s first MR-conditional pacemaker, Dougherty said, explaining that with the Revo, doctors couldn’t do a chest scan between certain vertebrae. That restriction has been removed with the Advisa.
“The FDA approval of the Advisa MRI System Study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the MRI environment,” Pat Mackin, president of the cardiac rhythm disease management business and senior VP at Medtronic, said in a news release.
In the U.S., Medtronic, which ranked 5th on the MassDevice Big 100 list of the world’s largest medical device companies, is far ahead of competitors in developing MRI pacemaker technology. It introduced the RevoSureScan pacing system earlier this year, and no other company has a similar product out in the marketplace, let alone a second iteration.
An estimated 200,000 people implanted with pacemakers forego MRI scans every year because the scans disrupt the proper functionality of the pacemakers.
Adoption of Medtronic’s MR-conditional pacemakers and others that follow will likely be helped by the Centers for Medicare & Medicaid Services reversing its earlier decision regarding reimbursement. Medicare now pays for MRI scans on patients who are implanted with such pacemakers, Dougherty confirmed.