St. Jude Medical Announces FDA And European CE Mark Approvals Of Durata Defibrillation Lead, USA

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Jan 2008 - 3:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of the Durata(TM) defibrillation lead, the company's next generation high voltage lead. The announcement was made at the 13th Annual International Boston Atrial Fibrillation Symposium in Boston, Mass.

Durata features a soft silicone tip with a larger surface area and a slightly-curved right ventricle (RV) shock coil, intended to enhance ease of use and handling for implanting physicians. The Durata lead also incorporates Optim(R) insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

"The Durata's softer tip and curved coil allow me more control during implant procedures, as well as more options for lead placement," said Stephen Stark, M.D., clinical professor of medicine, UC Davis Medical Center Electrophysiology Laboratory in Sacramento, Calif. "These technological advancements, combined with the thin diameter of the Durata lead, make it easier to implant and to accommodate additional leads if they are needed."

The Durata lead is the same size as the company's Riata(R) ST high voltage lead, which at 7 French, are the smallest diameter leads on the market. Small diameter leads may be especially helpful for patients with compromised blood flow or a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

Durata is one of several models of implantable cardioverter defibrillator (ICD) leads sold by St. Jude Medical. Published data from two large, prospective registries have affirmed the performance and reliability of St. Jude Medical lead products. St. Jude Medical will continue to offer all prior models of its high voltage leads to physician customers.

All St. Jude Medical Durata, Riata ST, and Riata ST Optim ICD leads have additional exclusive features including:

-- Flatwire technology with complete silicone backfill designed to prevent tissue in- growth.

-- Dual, redundant cables designed to increase reliability, so that if one cable is damaged another will provide backup.

-- Single- and dual-coil design with 17 and 21 cm shock coil spacing, which gives physicians more options when selecting the most appropriate lead for individual patient anatomy.

"We are committed to continuous improvement at St. Jude Medical and are constantly evolving our product lines to incorporate new, advanced features, based on physician feedback, to better serve our physician customers and their patients," said Eric S. Fain, president of St. Jude Medical's Cardiac Rhythm Management Division. "By combining next-generation technology with multiple features designed to increase the reliability and durability of our ICD leads, we are confident that the Durata lead will excel in both performance and reliability for patients."

A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker or ICD. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.

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.

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