NEW PRODUCTS
Medtronic Inc., Fridley, announced the first U.S. implant of the Evera MRI SureScan implantable cardioverter-defibrillator system, following Food and Drug Administration approval of its investigational device exemption application and pivotal clinical-trial protocol. Evera MRI is the first ICD system to be evaluated in the U.S. that allows for magnetic resonance imaging (MRI) scans positioned on any region of the body. The first device was successfully implanted at Marquette General Hospital in Marquette, Mich., as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at about 45 centers. The Evera MRI ICD System is available only for investigational use in the United States.
