Medtronic (NYSE:MDT) said today that it won FDA approval for its full suite of MRI-safe cardiac rhythm and heart failure devices and leads for 3- and 1.5-Tesla scans, touting the approval as the 1st of its kind in the U.S.
The regulatory win allows current patients with Fridley, Minn.-based Medtronic’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators and leads to undergo MRI scans anywhere on their body.
“The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians. Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool,” Dr. Marc Silver of Raleigh, N.C.’s WakeMed Heart and Vascular Physicians group said in a press release.
Included in the expanded indication are Medtronic’s Advisa MRI pacemakers, Micra transcatheter pacemakers, Amplia MRI and Compia MRI CRT-Ds, Evera MRI and Visia AF MRI DF1 and DF4 ICDs, Reveal Linq insertable cardiac monitor and the SureScan pacing, defib and left-heart leads, the company said.
“While 1.5T scanners still comprise the majority of installations, 3T scanners are expected to comprise more than half of new units – with some centers having only 3T scanners – since they offer faster scans and higher resolution images. Approval for MRI conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care. And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine,” Pharmascan Clinical Trials chief medical officer Dr. Yair Safriel said in prepared remarks.
The company said the MRI-safe approval allows it to offer more options to ICD patients undergoing device replacement surgery, which will open up MRI access to a broader base of patients.
“Our goal is to help patients get the cardiac device therapy they need while ensuring they also retain access to other needed tools, such as diagnostic MRI. We are proud to be the first and only company to offer a comprehensive suite of MR-conditional devices and leads in the U.S.,” Medtronic heart failure GM Dr. David Steinhaus said in a prepared statement.
Late last month, Medtronic said it issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion.
The company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues with 78 specific Viva CTR-D and Evera ICDs related to a specific subset of circuit components which may have a low resistance path that could result in rapid battery depletion.
