Medtronic updates us on U.S. progress towards U.S. market of its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. Following U.S. FDA approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol, the device has become 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 has now been successfully implanted.
Background
It’s a source of perpetually raised eyebrows, this notion that a device or technology that is deemed acceptable for use in European patients, remains “investigational” in the United States, but as long as we have different approaches to regulation of medical devices, that’s how it will remain. Whether you vote for more protection for patients against “unproven” technology, or whether you’d prefer to take a chance in pursuit of an advance, is your call, and a rather academic one, given that there’s not much you can do about it.
Medtronic refers to a study which shows that 63 percent of ICD patients will need an MRI within 10 years of receiving a device. And because no ICD has yet been FDA approved for use in whole body MRI scans, patients are being denied this tool, while Europeans have full access now that the Evera device has gained its CE mark.
Medtronic recently gained the FDA’s nod to commence its IDE study into Evera, and the device has now seen its first implant performed at the Marquette General Hospital in Marquette, Mich., by Mark Cowan, M.D., as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.
Physician comments
“ICD patients in the U.S. are frequently denied access to MRI, and results from this clinical trial may give us the evidence needed to make MRI standard,” said Michael R. Gold, M.D., Ph.D., Michael E. Assay professor of medicine and director of cardiology at the Medical University of South Carolina, and principal investigator in the study. “We are optimistic about the possibilities that may be ahead for ICD patients, many of whom will need MRI scans during their lifetimes. Adding an ICD that would allow patients to have full-body access to MRI would be a significant breakthrough for this patient population.”
Company comments
“Our goal with the Evera MRI system is to give patients the most unrestricted access to MRI scans, and ultimately allow them to get the diagnostic answers they need,” said Marshall Stanton, M.D., vice president and general manager of the tachycardia business at Medtronic. “Medtronic has been a leader in developing implantable devices that are safe for the MRI environment, and we believe ICDs will be no exception in the near future.”
Source: Medtronic, Inc.
