Medtronic has started enrolling patients in a US pivotal clinical trial to evaluate the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System.
The move follows the US Food and Drug Administration (FDA) approval for the company’s Investigational Device Exemption (IDE) application and pivotal clinical trial protocol.
According to the company, Evera MRI is the first ICD system to be assessed in the US that allows for magnetic resonance imaging (MRI) scans positioned on any region of the body.
The first device was implanted at Marquette General Hospital in Marquette, by Mark Cowan, as part of the Medtronic randomised, global pivotal clinical trial that will enroll around 275 patients at about 45 centers.
Currently, the Evera MRI ICD System is available only for investigational use in the US.
Medical University of South Carolina professor of medicine and director of cardiology and principal investigator in the trial Michael Gold said ICD patients in the US are frequently denied access to MRI, and results from this clinical trial may give us the evidence needed to make MRI standard.
"We are optimistic about the possibilities that may be ahead for ICD patients, many of whom will need MRI scans during their lifetimes," Gold said.
"Adding an ICD that would allow patients to have full-body access to MRI would be a significant breakthrough for this patient population."
The company said that Evera MRI is designed to better fit inside the body, with a contoured shape and thin, smooth edges that increase patient comfort by reducing skin pressure by 30%.
Medtronic vice president and general manager of the tachycardia business Marshall Stanton said the company’s 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.
"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," Stanton said.