St. Jude, Medtronic Win MRI-Compatible FDA Approvals

The trend toward MRI-compatible implants continues as Medtronic and St. Jude Medical announce FDA approvals for MRI-compatible devices.

Medtronic racked up another FDA approval for an MRI-compatible cardiac rhythm device while St. Jude Medical also announced agency approval for MR-conditional labeling of a spinal cord stimulation system.

The regulatory approvals, both announced November 14, are the latest developments in an industry-wide trend toward MRI-safe implants. 

In October, Medtronic announced FDA approval for use of 1.5T and 3T MRI scans with many of its implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy debribillators (CRT-Ds), and pacemakers. Now, the company has secured the agency's approval for another MRI-conditional CRT-D, the Claria MRI Quad CRT-D SureScan. The device can be used during MRI scans with both 1.5T and 3T systems. 

The Claria MRI CRT-D also uses Medtronic's new EffectivCRT algorithm, which has the capability to determine left ventricular pacing efficacy, sense when a patient is experiencing an atrial fibrillation (AF) episode, and adjust pacing during an AF episode, according to a company release.

"With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT," Suneet Mittal, MD, director of the Electrophysiology Laboratory at the Arrhythmia Institute of the Valley Health System in Ridgewood, NJ, said in the release.

Medtronic has been a leader in MRI-safe cardiac rhythm management devices, having gained the first FDA approvals for an MR-conditional pacemaker in 2011 and an MR-conditional ICD in 2015. 

MR-conditional labeling is important for medical devices implanted in other parts of the body too. St. Jude Medical announced that its Proclaim Elite Spinal Cord Stimulation (SCS) System has received FDA approval for full-body MR-conditional labeling. The Proclaim Elite SCS System has been available to U.S. chronic pain patients since November 2015. That approval included approval for MRI scans of the head and extremities.  

"The addition of full-body MR Conditional labeling for the Proclaim Elite SCS system will be another critical benefit for my patients and will help me ensure those who may one day need an MRI can benefit from St. Jude Medical's innovations without fear of putting themselves and their implant at risk," Steven Falowski, MD, chief of functional neurosurgery at St. Luke's University Health Network in Bethlehem, Pennsylvania, said in the company release.

St. Jude Medical is waiting on FDA approval for its MRI-safe pacemaker, anticipated in the fourth quarter of 2016. The portfolio gap has pressured sales for the company in the United States. According to a Seeking Alpha transcript of the company's third quarter earnings call, Michael Rousseau, St. Jude Medical president and CEO, said,"Our traditional CRM franchise remains challenged in the U.S., primarily due to the fact that we do not have an MRI-safe device approved."

The company's management also anticipates filing an FDA submission for an MRI-safe high-voltage device by the end of the year, with an approval expected in the first half of 2017.

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