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FDA Clears St. Jude Medical's MR-Conditional Spinal Cord Stimulation System.

M2 PHARMA-April 30, 2015-FDA Clears St. Jude Medical's MR-Conditional Spinal Cord Stimulation System


The US Food and Drug Administration has approved US-based medical device company St. Jude Medical, Inc.'s (NYSE: STJ) Protege MRI spinal cord stimulation system, the company said on Thursday.

In addition to the approval of the new Protege MRI system, St. Jude Medical has also secured FDA approval for MRI compatibility of the company's 60cm Octrode percutaneous leads, which has received MR-conditional labeling for use with the Protege MRI system.

The Protege MRI system is the smallest MR-conditional SCS implantable pulse generator available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity MRI scans, St. Jude said.

Upgradeable technology allows patients to access future SCS technology from St. Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.

Chronic pain affects more than 100m Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515m workdays annually and generates upwards of 40m visits to physicians each year.

SCS therapy can offer proven, meaningful chronic pain relief for many patients while improving quality of life and reducing or even eliminating a patient's use of pain medication. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.

In addition to the approval of the Protege MRI system, St. Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including their flagship Penta paddle lead, in order to allow more patients the ability to safely undergo MRI scans.

St. Jude Medical also plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.

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Publication:M2 Pharma
Date:Apr 30, 2015
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