Medtronic gets FDA approval for clinical trial on new MRI with pacemaker product

The U.S. Food and Drug Administration has given Medtronic the go-ahead on a clinical trial to test its next generation of MRI pacemaker technology, the Minnesota company announced Monday.

The maker of new innovative medical devices can enroll up to 250 patients in 50 medical centers across Europe, Central Asia, the United States, Canada and Australia, said Medtronic spokeswoman Wendy Dougherty, to test the new device — the Advisa DR MRI SureScan pacing system. It is 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,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, in a news release.

In the United States, Medtronic is far ahead of competitors in developing MRI pacemaker technology. It introduced the RevoSureScan pacing system earlier this year. No other company has a similar product out in the marketplace, let alone developing its next iteration. St. Jude Medical’s Accent MRI pacemaker is available in some overseas locations. Boston Scientific is developing one. It is estimated that about 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 and Medicaid Services reversing its earlier decision regarding reimbursement. Medicare now pays for MRI scans on patients who are implanted with such pacemakers, Dougherty confirmed.

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