|St. Jude Medical Comments on MAUDE Database Report about Durata Lead|
Analysis of lead from
Through our investigation of the MAUDE database report submitted to the
The identified lead was explanted at a
Through our investigation, we have identified that the patient had an additional defibrillation lead that had been capped (and was no longer being used). In the fluoroscopic images, the two leads cross in the region mentioned in the filed MAUDE report. Based upon physical examination, our analysis indicates the damage to the Durata lead is consistent with external abrasion from contact with a calcified, or hardened, heart valve or possibly from lead-to-lead contact. External abrasion is a known cause of failure across all cardiac leads in the industry, which is different from the inside-out abrasion seen with externalized conductors observed in some Riata leads.
We recognize the importance of providing physicians with up-to-date and accurate information in a timely and responsible manner so that they can make informed patient care decisions. This case highlights the importance of appropriate analysis in determining the root cause of lead damage. It is our desire to work closely with physicians to understand the circumstances surrounding a device malfunction. We encourage physicians to report any case of lead failure to the manufacturer for further inspection and analysis to best ensure we are able to validate and communicate information in the interest of patient safety.
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