Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - April 18, 2011

St. Jude Medical Announces European Approval of Accent MRI Pacemaker System

New innovative pacing system designed and tested for safe MRI performance

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced that it has received European CE Mark approval for its Accent MRI™ pacemaker and Tendril MRI™ lead. The system, designed and tested for safe use in a Magnetic Resonance Imaging (MRI) environment and approved as MR-Conditional, allows patients to undergo full-body, high-resolution MRI scans.

“The Accent MRI pacemaker system meets important clinical needs without compromise by offering superior pacing technology in addition to full MRI-compatible scanning capabilities with no anatomical zone or MRI power restrictions,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division.

Each year, approximately one million pacemakers are implanted worldwide, and up to 75 percent of pacemaker patients could benefit from MRI scans during the lifetime of their devices. The new Accent MRI pacemaker system is an advanced pacing platform that provides wireless telemetry and algorithms to address individual patient conditions, with the added benefit of MRI scanning capability.

“Many of my patients have faced severe health problems, such as cancer, stroke and neurological disorders, for which MRI is fast becoming the preferred diagnostic tool,” said Burkert Pieske, M.D., chief of cardiology at University Hospital Graz in Graz, Austria. “Until recently, many of my pacemaker patients were contraindicated for an MRI, but the new Accent MRI system allows my patients a full-featured pacemaker with access to full-body scanning to address their additional health concerns.”

The system features an MRI Activator™ device that provides a simple alternative option for programming the device to the appropriate MRI mode for use during the scan. Since it does not require a programmer, this increases both clinical and personnel efficiency. A single button press on the handheld MRI Activator device can be used to program the specific device parameters to be used during the MRI scan. These parameters are pre-selected by the patient’s physician and stored in the Accent MRI pacemaker. The MRI Activator can then be used to program the device back to its original settings after the scan has been completed.

“The Accent MRI pacemaker system offers MRI capabilities without any trade-offs,” said Karlheinz Tscheliessnigg, M.D., chief of cardiac surgery at University Hospital Graz in Graz, Austria. “The device is not only an advanced pacemaker that allows for efficient patient management, but it also features the Tendril MRI lead that gives me the flexibility to easily maneuver the lead into position because of its excellent handling characteristics.”

The Tendril MRI pacing lead, built on the proven Tendril lead platform, offers unique design advantages for safe, MR-Conditional scanning. The thin diameter makes it easier for physicians to implant, as it retains the handling characteristics of the well established Tendril platform of pacing leads. In addition, the lead features Optim™ lead insulation, the first silicone-polyurethane co-polymer material created specifically for cardiac lead use. The Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.

In addition, the Accent MRI pacemaker system features InvisiLink™ telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or through remote monitoring via the Merlin.net® Patient Care Network (PCN), a secure, Internet-based remote care system. The Merlin.net PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and remote transmissions sent from a patients home, allowing for more efficient and convenient care and device management, including the ability to perform a full interrogation of the pacemaker at home after the patient completes their MRI study.

The Accent MRI pacemaker has several features that simplify patient management. These features include AutoCapture® Pacing System technology that measures the heart’s reaction to pacing beat-by-beat, and the VIP® algorithm that enables the heart’s intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

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 1, 2011. 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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