Healthcare Industry News:  neuromodulation 

Devices Neurology FDA

 News Release - July 20, 2015

St. Jude Medical Announces FDA Approval for Industry's Only MR-Conditional 5-Column Paddle Lead for the Management of Chronic Pain

New MR-conditional labeling for the Penta paddle lead ensures patients in need of future MRIs can access the industry’s broadest paddle lead to support the treatment of chronic pain

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of MR-conditional labeling for the company’s Penta™ 5-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 U.S., 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 (IPG’s) 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 labeling, 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 U.S. In an SCS system, an IPG generates electrical energy, which is delivered via leads to nerve fibers along the spine to interrupt pain signals as they travel to the brain, reducing the sensation of pain.

The St. Jude Medical Penta paddle lead is designed to provide physicians the broadest area of lateral stimulation coverage available (9mm), which supports selective stimulation of nerve fibers 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 fibers. Such specific targeting allows physicians to tailor therapy to a patient’s unique pain pattern.

"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,” said Eric S. Fain, M.D., 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.”

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

About the St. Jude Medical Chronic Pain Portfolio

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact mood, personal relationships, work productivity, and activities of daily living. St. Jude Medical offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation (SCS) and radiofrequency ablation (RFA).

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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