FDA Approves First MRI-Safe ICD in the United States

Medtronic plc received what it claims is the first U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans.

The Medtronic Evera MRI SureScan ICD System is approved for MRI scans on any part of the body without positioning restrictions. The newly approved system, which will be commercially available this month, includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional.

“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 Michael R. Gold, M.D., Ph.D., chief of cardiology, Michael E. Assey professor of medicine at the Medical University of South Carolina, and principal investigator in the Evera MRI Clinical Trial. “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.”

Sudden cardiac arrest (SCA) is a sudden, abrupt loss of heart function that can result in death if not treated within minutes with an electrical cardioverter shock, which can be delivered by an ICD. MRI is considered the gold standard in soft-tissue imaging and is used regularly for the diagnosis of conditions such as stroke, cancer, Alzheimer`s disease, and muscle, bone and joint pain.

Until now, patients with ICD systems have been contraindicated by the FDA from receiving MRI scans because of potential interactions between the MRI and device function, which might result in risk to patients. These MRI restrictions have resulted in a critical unmet need as data have shown that, within four years, more than one-third of patients with ICDs—36 percent—are likely to need an MRI, according to figures cited by the company.

The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the Evera MRI Clinical Trial, a multicenter, prospective, randomized, controlled clinical trial that enrolled 275 patients at 42 centers around the world. Presented during a late-breaking clinical trial session at Heart Rhythm 2015, the Heart Rhythm Society’s 36^thAnnual Scientific Sessions, and published in the Journal of the American College of Cardiology (JACC), these data demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.

“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,” said Marshall Stanton, M.D., vice president and general manager of the Tachycardia business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic. “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.”

Other cardiovascular companies, such as Germany’s Biotronik are pursuing MRI-safe implantable cardiovascular technology such as ICDs and pacemakers. Biotronik, which has FDA-approved pacemaker technology, is pursuing FDA approval of its own ICD with its ProMRI study.The company has MRI-safe ICD technology cleared in Europe, as does Boston Scientific Corp.