St. Jude Medical has won FDA 510(k) clearance for its Protégé MRI spinal cord stimulation system, the smallest MR-conditional SCS implantable pulse generator commercially available in the U.S., the St. Paul, Minn., devicemaker announced Thursday. The company also announced FDA approval for MRI compatibility of its 60-cm Octrode percutaneous leads, which have been indicated for use with the device.
The system is the only upgradeable IPG that enables patients to safely undergo MRI scans of the head and extremities, the company says.
Upgradeable technology means patients can access future SCS St. Jude technology through software updates instead of surgical device replacement, which has historically been the norm.
CE Mark approval is pending for the devicemaker’s Prodigy system, which offers Burst stimulation, a technique not approved in the U.S., a spokeswoman told Device Daily.
SCS therapy is used as a treatment for chronic pain, which affects more than 100 million people in the U.S. — Jason Scott