St. Jude Medical, Inc. (NYSE: STJ) announced that it has distributed a programmer software upgrade to eliminate a random, low-frequency anomaly that could affect ventricular sensing in the Epic™ and Atlas™ families of implantable cardiac defibrillators.
Specifically, a potential loss of ventricular sensing has been attributed to an extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. To date, an incidence of 0.00006 of the subject device population (eight out of approximately 143,000 implanted since July 2002) has been found to exhibit a loss of ventricular sensing. Although the company has not received any reports of adverse events or clinical complications associated with the anomaly and the rate of incidence is very low, the company has chosen to take a conservative and transparent approach in advising the medical community and regulatory agencies.
The new software will be downloaded into the device during a patient's next routine check up and will fully prevent the anomaly from occurring in the future. The simple, non-invasive software upgrade can be completed in approximately 10-20 seconds, during which time the device will maintain full functionality. St. Jude Medical, in consultation with its independent Medical Advisory Board members, has determined that no other action is recommended.
The company is in the process of distributing the programmer software to its physician customers. A copy of the physician communication can be found
here.
The company does not expect this matter to have any material financial impact.
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 sjm.
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 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
St. Jude Medical