St. Jude Medical wins MR-conditional nod from FDA for Penta chronic pain lead

St. Jude Medical (NYSE:STJ) said today that the FDA approved MR-conditional labeling for its Penta spinal cord stimulation lead for treating chronic pain.

The 5-column Penta paddle lead is designed to be used with St. Jude’s Protégé MRI device, the company said, claiming it as the only such lead on the U.S. market to “allow patients to safely undergo head and extremity MRI scans.” Protégé MRI won pre-market approval from the FDA in April.

“We are excited to receive MR-conditional labeling approval for our Penta paddle lead alongside the recent approval of the Protégé MRI system and MR-conditional labeling for our Octrode percutaneous leads,” group president Dr. Eric Fain said in prepared remarks. “When taken together, the approvals of these products in our chronic pain portfolio represent a critical component to growing our neuromodulation business and improving access to our industry-leading chronic pain therapies for patients who may need future head and extremity MRI scans.”

Last week St. Jude won approval from the FDA for its Invisible Trial app for testing its spinal cord stimulation devices. In June, the company said the Axium dorsal root ganglion neurostimulator it acquired for $215 million in May showed superior pain relief compared to traditional spinal cord stimulation in the 152-patient Accurate study.

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