St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has posted information from the MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal.
Dr. Hauser’s review of the number of deaths in the MAUDE database was wrong by greater than a factor of six. Information on all 377 reports for the Medtronic Quattro Secure lead are available on the St. Jude Medical Riatacommunication.com website.
The company has called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing the St. Jude Medical Riata® and Riata ST leads to the Medtronic Quattro Secure device. The company also invites Medtronic to review the MAUDE database report findings.
Visit Riatacommunication.com to review the 377 MAUDE database reports.
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.
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 December 31, 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.Business Wire
Last updated on: 10/04/2012