St. Jude Medical announced today that its Protégé MRI spinal cord stimulation (SCS) system received FDA approval. The company also got FDA approval for MRI compatibility of its 60cm Octrode percutaneous leads, which are used with the Protégé MRI system.

SCS therapy provides relief for patients suffering from chronic pain, improving their quality of life and reducing or eliminating the use of pain medication. But patients who frequently require MRI exams, were not able to receive SCS therapy until now.

According to the American Academy of Pain Medicine, 100 million American suffer from chronic pain. More Americans are affected by pain than diabetes, heart disease and cancer combined.
The Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) in the U.S., according to St. Jude Medical. It’s also the only upgradable IPG that enables chronic pain patients to undergo head and extremity MRI exams safely.

Since it's upgradeable, it means that patients can receive future SCS technology through software upgrade, once approved. Previously, patients had to undergo a surgical procedure to receive the new product features.

St. Jude Medical is also planning to work on updated labeling for its Penta paddle lead, so more patients can safely undergo MRI exams. The company will also be submitting testing data that supports full-body MR-conditional scan labeling for future SCS systems.

More Industry Headlines