Medtronic PLC received PMA in September for the first implantable cardioverter defibrillator (ICD) system for use with an MRI scan. The patient population that will benefit from the Evera MRI SureScan ICD System is already indicated for an ICD: those at risk for sudden cardiac arrest (SCA) or ventricular arrhythmias. “ICDs have been saving lives for more than 30 years by delivering a lifesaving shock or painless pacing to stop life-threatening fast or irregular heartbeats,” says Marshall Stanton, MD, vice president and general manager of the tachycardia business at Medtronic. “However, prior to this approval, FDA had contraindicated ICD patients from receiving MRI scans because of potential interactions between the MRI magnet and implanted device.” Further, the Centers for Medicare and Medicare Services (CMS) “does not reimburse MRI scans done on patients who have ICDs or pacemakers that are not labeled for use in MRI scanners,” Stanton notes.

The added benefit of the Evera MRI ICD over non-MRI ICDs is that patients can safely undergo an MRI scan – considered the gold standard for soft-tissue imaging – which may be ordered by a physician to help diagnose another condition. And although the MRI-compatible system does not expand the indications of those who qualify or are indicated for an ICD, “it does grant ICD patients access to an important imaging modality for the diagnosis of conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and joint pain,” Stanton says.

Medtronic does not divulge specific product pricing; however, implanted defibrillators generally cost roughly between $20,000 and $30,000. Medicare has also established a national coverage decision (NCD) for ICDs, for which reimbursement may vary based on private coverage. “We believe physicians value the opportunity to give their ICD patients access to MRI,” Stanton conveys. “Because Medtronic is Medtronic PLC, physicians may choose Medtronic instead of another manufacturer, which would increase the company’s share. For example, in Japan, we have seen double-digit share gains since the launch of the system last November in that country.”

Michael Gold, MD, PhD, chief of cardiology at the Medical University of South Carolina in Charleston, was global lead investigator of the Evera MRI Clinical Trial that enrolled 275 patients at 42 centers. “The device performed very well. There was no impact of MRI on sensing of cardiac rhythm or the threshold for pacing the heart,” says Gold, who presented results of the study in May at Heart Rhythm 2015 in Boston and published them concurrently in the Journal of the American College of Cardiology (JACC). “Moreover, there were no complications associated with having MRI scans in this group of patients.”

The non-MRI-compatible Evera was modified to minimize the impact that magnetic fields of an MRI have on device function, such as filtering characteristics. In addition, there are special features within the device to inactivate defibrillation function while in an MRI scanner. “Specific leads were also chosen that are MRI safe,” Gold conveys. Going forward, the MRI-compatible system “will allow open access to patients to have MRI scans, regardless of their cardiac rhythm and regardless of what part of the body is scanned. Patients can be scanned even if they have heart block or require pacing through their device.”

Gold says hundreds of thousands of people worldwide have been implanted with ICDs. “Studies have shown, however, that those patients with an ICD are about 50-fold less likely to get MRIs following a stroke than those patients who do not have an ICD,” he explains. “We know that the presence of an ICD markedly reduces important imaging studies in patients with devices.”

Gold says there are several factors that will likely influence adoption of the Evera MRI ICD system. “As we learned from MRI pacemakers, it does not become 100% of the market overnight,” he notes. “Some physicians or hospitals may prefer a different manufacturer. There may also be cost concerns. But I think most people would agree that an MRI-compatible ICD will become the standard in the very near future, as all companies and all devices will be MRI safe. Still, Medtronic being the first to market offers the company a substantial lead to gain market share.”

Adds Stanton of Medtronic, “MRI scans allow physicians to make a wide range of health diagnoses by viewing highly detailed images of internal organs, blood vessels, muscle joints[muscle and joints?], tumors, areas of infection and more, without X-rays, surgery or pain. The number of MRI scans performed increases each year, as does the number of people with implanted cardiac devices. In fact, published studies have shown more than one third of patients who receive an ICD are likely to need an MRI within four years.”

In the cardiac rhythm and heart failure (CRHF) space, Medtronic offers MRI-conditional pacemakers, implantable defibrillators and insertable cardiac monitors. Additionally, some company implanted neurostimulators are MRI conditional.

Medtronic has submitted a premarket application to the FDA for an MRI-conditional cardiac resynchronization therapy-defibrillator (CRT-D) system. “Medtronic is the leader in bringing MRI-conditional implantable cardiac devices to patients,” Stanton relates. The company has more than 18 years of MRI research experience, and began developing testing and modeling capabilities back in the 1990s. “More than 3,700 patients have been enrolled in Medtronic SureScan pacemaker and ICD prospective clinical studies, and multiple manuscripts have been published on the clinical testing of our MRI systems,” Stanton says.

In 2008, Medtronic was the first to offer an MRI-compatible pacemaker in Europe, and in the US in 2011. “Now we are pleased to be able to offer an MRI-compatible ICD to protect patients from ventricular arrhythmias and SCA, while granting them access to an important diagnostic,” Stanton says. (See [A#01150921004].)

Medtronic’s MRI-Compatible ICD System Receives FDA Approval

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