Medtronic’s Evera Clinical Trial Meets Endpoints
Medtronic has announced positive clinical trial results for its Evera MRI SureScan implantable cardioverter defibrillator.
The Irish devicemaker says study results show the ICD’s ability to detect possibly dangerous heart rhythms and administer therapy is not affected by MRI scans. The clinical trial is the first ICD study to encompass full-body MRI scans.
ICD patients are contraindicated from receiving an MRI because of interaction risks involved with their devices. Up to 64 percent of these patients will require MRI scans within 10 years of implantation, the company says.
Evera won CE Mark approval in 2014. In the U.S., the device is limited to investigational use only. — Jason Scott