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St. Jude Medical obtains FDA approval for MR-conditional 5-column paddle lead

Medical device firm St. Jude Medical has received approval from the US Food and Drug Administration (FDA) for MR-conditional labeling of the Penta 5-column paddle lead for spinal cord stimulation (SCS) therapy to manage chronic pain.

Available for use with the firm’s Protégé MRI system in the US, the Penta lead is claimed to be the only five-column paddle lead that will enable patients to undergo head and extremity MRI scans.

The Penta paddle lead has been developed to provide broadest area of lateral stimulation coverage of 9mm for physicians, which supports selective stimulation of nerve fibers associated with a patient’s pain without needlessly stimulating other areas.

St. Jude Medical group president Dr Eric Fain said: "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.

"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."

In this year, the company introduced a series of MR-conditional implantable pulse generators (IPG’s) and leads, in a bid to improve patient access to the latest chronic pain therapy options.