Medical Technology

FDA lifts restrictions on Spinal Cord Stimulation System

The company announced that the US Food and Drug Administration (FDA) has approved a revised labeling system to increase MRI compatibility for Abbot’s Proclaim XR spine cord stimulation (SCS).

The FDA first approved the Proclaim XR neurostimulation system for patients suffering from chronic pain in the year 2019, as reported at the time by Medscape Medical News.

The new labeling eliminates MRI limitations regarding the placement of the Octrode lead leads. The lead tips of 60 cm can be placed anywhere along your spine. They remain “MR conditional.”

The new labeling removes limitations on the power of radiofrequency which can still be utilized in the normal operating mode of an MRI scan. Radiofrequency energy does not have to be limited with Octrode and Proclaim devices so long as the MRI is in normal operating mode.

Patients with a Proclaim XR SCS device have to wait for only 30 minutes between scan cycles lasting 30 minutes.

In general, the FDA requires radiologists to pause MRIs for 30 to 60 minutes between scan cycles for patients with implants.

Abbott stated in an announcement in the press that patients with the Proclaim XR SC device can enjoy higher quality images as well as faster MRI scan times under the expanded MRI labeling.

“The expanded labeling and reduced scan time address two of the major issues we face with these implantable devices,” Steven Falowski, MD neurosurgeon at Neurosurgical Associates of Lancaster in Pennsylvania added in the same release.

“By improving the quality of imaging, and the overall experience for both the patient and the radiologist I am now able to allow more of my existing and new patients to benefit from MRI scans, which improve their treatment,” Falowski said.

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