Medtronic urges CMS to cover MRI-safe pacemakers
Medtronic has requested that the Centers for Medicare & Medicaid Services (CMS) revise national coverage determination (NCD) for cardiac pacemakers to include coverage for devices that have been designed, tested and FDA labeled for use in the MRI environment.
The Minneapolis-based medical device maker said that a cardiac pacemaker system has been developed that allows patients to safely undergo MRI scans. Furthermore, the company wrote that there is sufficient evidence to modify the current NCD.
The company obtained the CE Mark for its system in September 2008 and has been marketing it in Europe. In the U.S., the product is considered investigational, currently undergoing clinical study. Medtronic said it is actively pursuing FDA approval.
Medtronic requested that the language in the CMS' NCD be revised to say: "The MRI is not covered when the following patient-specific contraindications are present. It is not covered for patients with devices that have not been approved or cleared by the FDA for use in the MRI environment."
The Minneapolis-based medical device maker said that a cardiac pacemaker system has been developed that allows patients to safely undergo MRI scans. Furthermore, the company wrote that there is sufficient evidence to modify the current NCD.
The company obtained the CE Mark for its system in September 2008 and has been marketing it in Europe. In the U.S., the product is considered investigational, currently undergoing clinical study. Medtronic said it is actively pursuing FDA approval.
Medtronic requested that the language in the CMS' NCD be revised to say: "The MRI is not covered when the following patient-specific contraindications are present. It is not covered for patients with devices that have not been approved or cleared by the FDA for use in the MRI environment."