Healthcare Industry News:  Advamed 

Devices Cardiology

 News Release - September 28, 2006

St. Jude Medical Comments on Heart Rhythm Society Recommendations on Device Performance Policies and Guidelines

Company Remains Committed to Innovative, Quality Devices and Transparent Communications to Benefit Patients and Physicians

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc., (NYSE:STJ ) today commended the Heart Rhythm Society (HRS) for engaging industry stakeholders, including physicians, patient groups and the U.S. Food and Drug Administration, in developing its recommendations on device performance policies and guidelines as announced earlier today.

"We recognize the important role that communications can play in helping our stakeholders understand that ICDs and pacemakers save thousands of lives and are safer and more reliable than ever," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management (CRM) business. "St. Jude Medical was an active participant with the HRS Task Force in the development of these final guidelines and strongly supports the principles outlined by HRS. In fact, many of HRS's recommendations pertaining to industry are best practices that have long been part of St. Jude Medical's program."

Coyle continued, "As a leader in offering state-of-the-art CRM technology, we appreciate that St. Jude Medical's products are implanted in individuals whose health and well-being depend on their performance. We believe that the timely disclosure of meaningful device safety information is essential and remain committed to ensuring St. Jude Medical's policies and procedures are consistent with that objective."

From product design through manufacturing and post-market surveillance, St. Jude Medical is dedicated to quality and patient safety at every level of the organization. The company has well developed, regularly audited, quality control systems in place that conform to internationally recognized performance standards. St. Jude Medical regularly publishes product performance reports to ensure that patients, the healthcare community and the general public are informed about the performance of its devices. For many years, an external committee of independent medical and clinical experts has been involved in the review of St. Jude Medical's product performance in advance of any potential field advisory.

In the spirit of continuous improvement, and as a result of St. Jude Medical's participation with the HRS Task Force on Device Performance Policies and Guidelines, the company has adopted or is in the process of adopting a number of new initiatives to further enhance its existing quality assurance and reporting processes:

Communication of Device Performance:
  • St. Jude Medical's semi-annual product performance reports have been updated to conform to Advamed's "Proposal for Uniform CRM Product Performance Reporting." This proposal sets forth definitions and requirements for product performance reports and seeks to provide physicians and their patients with a level of device performance information that is consistent across manufacturers.

  • St. Jude Medical has also expanded the independent advisory committees it uses to include separate Medical Advisory Boards (MABs) for Devices (i.e. pacemakers and ICDs) and lead products. In addition to their traditional role of reviewing specific product performance issues in advance of any potential field advisory, these MAB's will now also review St. Jude Medical's semi-annual product performance reports prior to their issuance.

  • St. Jude Medical has joined with the other leading CRM companies in committing to provide annual, industry standardized datasets of actual survival probability data so that expectations for industry-wide device performance will be available to patients and physicians. These datasets will complement the currently available St. Jude Medical specific survival probability data published on each of its marketed products in the Company's semi-annual product performance reports.

  • St. Jude Medical will supplement existing processes to adopt the standardized Physician Device Advisory Notification format recommended by HRS when a field advisory becomes necessary and will establish communications processes to directly notify patients when it is advisable to do so following consultation with its external Medical Advisory Boards. Information associated with field advisories will also be made available on our website.
Post-market Surveillance, Data Analysis, and Technology Enhancements:
  • St. Jude Medical has committed to the initiation of post-market registry studies for both leads and devices to provide on going data on device reliability performance in order to complement existing returned product and customer complaint methodologies.

  • St. Jude Medical has committed to work with Advamed and the other leading CRM companies to improve existing systems that encourage post-mortem interrogation and return of devices among physicians, hospitals and funeral homes.

  • St. Jude Medical also supports the HRS recommendation regarding expanded use of remote monitoring, wireless and patient notification technologies. St. Jude Medical was the first company to introduce remote monitoring technology for ICDs with its market release of the Housecall(TM) trans-telephonic monitoring system in 1999. Another industry first, St. Jude Medical earlier this year introduced the industry's first vibratory patient notification feature in its Epic II and Atlas II ICD families, which is of particular benefit to patients with hearing difficulties. St. Jude Medical remains committed to expanding the monitoring, notification and other safety-related features of its pacemaker, ICD and lead products.
"As we move forward to work with others in our industry on these important issues, we at St. Jude Medical will remain committed to innovative, quality devices and open communications to benefit patients and physicians," concluded Coyle.

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., the Company employs approximately 11,000 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, regulatory approvals, anticipated future product launches, 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 March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). 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

Issuer of this News Release is solely responsible for its content.
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