Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - April 2, 2008

St. Jude Medical Announces Japanese Approval of the Merlin Programmer for Pacemakers, ICDs and CRT Devices

New programmer will provide quick and easy device programming

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the Merlin™ Patient Care System, a universal programmer for cardiac resynchronization therapy (CRT) devices, implantable cardioverter defibrillators (ICDs) and pacemakers. The System is designed to allow quick and efficient programming at the time of implant and at patients’ follow-up visits.

The Merlin Patient Care System is a powerful, portable computer that is designed to help physicians efficiently conduct cardiac tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care. Physicians can quickly make changes to device therapy through the System’s LCD touch-screen to decrease follow-up time.

Patients with ICDs, pacemakers or CRT devices require regular follow-up examinations to ensure devices are programmed to provide appropriate therapy and to review a patient’s response to programmed therapy. If a patient's condition has changed, clinicians can reprogram device parameters with the Merlin Patient Care System to help protect the patient from abnormal heart rhythms.

“We developed the Merlin Patient Care System by observing clinicians in their working environments,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “We sought clinicians’ input and listened to their needs, then responded by creating an intuitive system that streamlines workflow and simplifies the programming process.”

Japan represents the second-largest market for medical devices in the world, and St. Jude Medical (formerly known in Japan as Getz Bros.) has been serving that market since 1925. With an increasingly aging population, there is a strong focus to offer state-of-the-art medical devices in Japan.

The Merlin Patient Care System includes numerous benefits for physicians and patients:
  • A user interface that makes the entire system fast to learn and use. This interface mimics the natural workflow of a clinic to make it easier for clinicians to operate.
  • Enhanced presentation of diagnostics, which consolidates and displays patient information so clinicians can make decisions more quickly.
  • State-of-the-art hardware and flexible options for future programmer features and accessories. The hardware increases speed and consumes less energy, allowing the system to weigh less. A lighter-weight programmer makes it easier for physicians and nurses to carry and store the programmer between both hospital and patients’ office visits.
  • A session summary screen, which shows a summary of tests performed during an ICD or pacemaker patient's follow-up exam.
"The Merlin Patient Care System offers significant advantages for clinicians in Japan, including access to a more comprehensive, streamlined patient implant and follow-up system,” said Paul Bond, president of St. Jude Medical Japan Co., Ltd. "St. Jude Medical is committed to the global healthcare community, as demonstrated by our significant presence in Japan and our responsiveness to the needs of the medical community in this country, region and around the world.”

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.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 Company’s Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). 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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