FDA approves MR-conditional paddle lead for management of chronic pain


St Jude Medical has announced US Food and Drug Administration (FDA) approval of MR-conditional labelling for the company’s Penta five-column paddle lead for spinal cord stimulation (SCS) therapy to manage chronic pain. The Penta lead, which will be available for use with the company’s Protégé MRI system in the USA, is the only five-column paddle lead on the market that will allow patients to safely undergo head and extremity MRI scans.

For some chronic pain patients, the potential need for future MRI scans has historically acted as a barrier to SCS therapy. Throughout 2015, St Jude Medical has introduced a series of MR-conditional implantable pulse generators (IPGs) and leads designed to improve patient access to the latest chronic pain therapy options while preserving the ability to undergo head and extremity MRI scans.

With the newly approved updated labelling, the Penta paddle lead will be available for use with the Protégé MRI system, which is the smallest upgradeable MR-conditional SCS IPG available in the USA.

The Penta paddle lead is designed to provide physicians the broadest area of lateral stimulation coverage available (9mm), which supports selective stimulation of nerve fibres associated with a patient’s pain without needlessly stimulating other areas. The broad coverage of the Penta five-column paddle ensures sufficient stimulation when physicians are faced with anatomical asymmetries or in cases where stimulation is needed in very specific clusters of nerve fibres. Such specific targeting allows physicians to tailor therapy to a patient’s unique pain pattern.

“We are excited to receive MR-conditional labelling approval for our Penta paddle lead alongside the recent approval of the Protégé MRI system and MR-conditional labelling for our Octrode percutaneous leads,” said Eric S Fain, group president of St Jude Medical. “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.”