St. Jude Medical krijgt CE-markering voor enige MRI-voorwaardelijke oplaadbare ruggenmergstimulator met Burst-stimulering

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), internationaal producent van medische apparatuur, heeft vandaag bekendgemaakt dat het een CE-markering heeft gekregen voor de voorwaardelijke etikettering inzake MRI voor zijn Prodigy MRI-systeem ter bestrijding van chronische pijn. Prodigy MRI is na zijn lancering de kleinste MRI-voorwaardelijke, te herladen en te implanteren impulsgenerator (IPG) op de markt. Daarnaast is dit het enige MR-voorwaardelijke systeem voor ruggenmergstimulering dat zowel de gepatenteerde Burst-stimulering van St. Jude Medical als de traditionele, tonische stimulering levert.

Naast de Prodigy MRI kregen ook de percutane Octrode- en de uit vijf kolommen bestaande Penta-contactpunten een voorwaardelijk etiket inzake MRI. Deze contactpunten zijn bovendien goedgekeurd voor gebruik in combinatie met Prodigy MRI. De Penta is het enige contactpunt, of lead, met vijf kolommen. Dit biedt ongeëvenaarde laterale dekking voor nauwgezette controle en stimulering van de zenuwen in het ruggenmerg, al naargelang de behoeften van de patiënt.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

 

St. Jude Medical Receives CE Mark for Industry’s Only MR-Conditional Rechargeable Spinal Cord Stimulator Approved to Offer Burst Stimulation

 

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval for magnetic resonance imaging (MRI) conditional labeling for the company’s Prodigy MRI™ chronic pain system with select leads. Upon its launch, the Prodigy MRI system will become the market’s smallest MR-conditional rechargeable implantable pulse generator (IPG), as well as the industry’s sole MR-conditional SCS system capable of delivering both St. Jude Medical’s proprietary Burst stimulation and traditional tonic stimulation.

In addition to the approval of Prodigy MRI, all Octrode™ percutaneous and Penta™ 5-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI. The Penta lead is the industry’s only five-column paddle lead, which offers unmatched lateral coverage to finely control current and stimulate spinal nerves based specifically on patient need.

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

The new Prodigy MRI system will ensure patient access to St. Jude Medical’s innovative portfolio of chronic pain solutions, such as the company’s Burst stimulation, while maintaining the option for patients who may need future head and extremity MRI scans. In addition to the approval of the Prodigy MRI system, St. Jude Medical has announced plans to seek updated labeling in key markets around the world for additional chronic pain products, and plans to submit testing data to support full-body MR-conditional labeling for their future SCS systems.

“Clinical experience suggests that while relief from chronic pain remains the primary need for patients seeking spinal cord stimulation therapy, some patients who may benefit from SCS therapy may also need future MRI scans,” said Dr. Athanasios Koulousakis, Head of Department Functional Neurosurgery, Spasticity and Pain, University Hospital in Cologne, Germany. “So while the number of SCS patients requiring future MRIs may be limited, it is still critical to remove barriers to diagnostic options. Yet just as critical is providing MRI capability in SCS solutions that provide access to new therapy options, such as St. Jude Medical’s Burst stimulation. The new Prodigy MRI system helps put all such requirements into one package for our patients.”

St. Jude Medical is the only company approved to offer patients Burst stimulation, which the company introduced to the market in 2014 with the launch of the original Prodigy™ chronic pain system. The therapy was introduced after nearly a decade of research and study in collaboration with Dr. Dirk De Ridder, who filed the therapy’s initial patents in 2005.

The addition of Burst stimulation to St. Jude Medical’s chronic pain portfolio offered patients access to a therapy proven to relieve pain more effectively than traditional SCS while also significantly reducing or eliminating paresthesia for most patients. Clinical studies have also shown Burst stimulation can also offer pain relief to patients who may have become unresponsive to traditional SCS.

“MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options,” said Eric S. Fain, M.D., group president of St. Jude Medical. “MRI compatibility for head and extremity will reduce treatment limitations or restrictions for chronic pain patients who may have future MRI needs. We want patients to have access to the most advanced therapies and technologies to effectively and safely reduce their chronic pain.”

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 personal relationships, work productivity and a patient’s daily routine. St. Jude Medical offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, targeted stimulation of the dorsal root ganglion (DRG) and radiofrequency ablation (RFA).

Spinal cord stimulation is a proven therapy used to manage chronic pain. SCS therapy uses a small implanted generator to deliver electrical pulses to the nerve fibers of the spinal column via thin wires, known as leads with electrodes. These electrical pulses mask or interrupt pain signals as they travel up the spinal cord to the brain, reducing pain sensation.

About Burst Stimulation

St. Jude Medical’s Burst stimulation is a proprietary neurostimulation waveform that functions independently from stimulation cycles and programming currently available from other SCS systems. Burst stimulation is engineered to mimic the natural firing patterns of the nerves in the body, and delivers closely-spaced pulses of electrical energy to a patient’s spinal cord to manage chronic pain. St. Jude Medical has led rigorous development and ongoing clinical study of Burst stimulation and is the only company approved to offer Burst therapy.

Burst stimulation may be an option for patients whose pain is not adequately controlled, or for those who lose therapeutic benefit over time with tonic SCS alone. Early research indicates that St. Jude Medical’s Burst stimulation may be able to deliver SCS therapy with reduced paresthesia, and may be more effective than tonic stimulation for some patients.

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.

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Contacts

St. Jude Medical, Inc.
Investor Relations
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Barbara Van Buyten
Tel 32 2 774 67 12
bvanbuyten@sjm.com

 

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