Medtronic (NYSE:MDT) said today that the FDA granted pre-market approval for its Evera MRI SureScan device, touting it as the 1st MRI-safe implantable cardiac defibrillator to win U.S. approval.
Fridley, Minn.-based Medtronic said the Evera device is approved for MRI scans of any body area. The device is expected to hit the market this month, including the ICD itself and Medtronic’s Sprint Quattro Secure MRI SureScan DF4 leads, which are required for the MRI-safe designation.
“The Evera MRI ICD system underwent comprehensive computer modeling of more than 2.3 million clinical scenarios and this information, combined with the safety data from the clinical trial, has resulted in this critical regulatory approval,” tachycardia business manager Dr. Marshall Stanton said in prepared remarks. “As pioneers in the development of implantable cardiac devices that can be used in an MRI environment, Medtronic is committed to ongoing innovation to address the clinical needs of physicians and patients.”
The FDA nod was based on data from Medtronic’s Evera MRI study, presented in May at the annual Heart Rhythm Society meeting in Boston. The study showed no MRI-related complications among 275 patients randomized 2:1 to receive a course of MRIs or no MRI scans. The study’s 2 main efficacy endpoints, changes to the minimal ventricular pacing threshold and R-wave amplitude, were also met.
“Patients at risk for sudden cardiac arrest have long relied on ICDs to monitor their hearts, detect dangerous arrhythmias and deliver the life-saving therapy needed to survive,” said principal investigator Dr. Michael Gold of the Medical University of South Carolina. “Many of these patients also need access to MRIs, so the approval of an ICD that can be used in an MRI environment is crucial, and can help provide patients with the peace of mind that they are receiving the best care available.”
The Evera MRI SureScan won CE Mark approval in the European Union in April 2014, the same month that Medtronic launched a U.S. investigational device exemption trial for the device.