St. Jude Medical Announces FDA Clearance And CE Mark Approval Of Strada Carotid Guiding Sheath

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 09 May 2008 - 2:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada™ Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada Carotid Guiding Sheath is designed specifically to provide easier and faster access to challenging carotid anatomy.

Each year, an estimated 350,000 people in the United States undergo either surgery or a procedure in which a stent, a tiny mesh tube, is inserted to restore blood flow through the carotid arteries.

The carotid arteries are vessels in the neck that supply blood to the brain, face and scalp. In carotid artery disease, a build-up of fatty deposits, or plaque, on the inside walls of the arteries can reduce or restrict blood flow to the brain. Plaque build-up can also lead to an embolism, where a clot or plaque that breaks away from the site at which it formed and lodges "downstream" in an artery to block blood flow. In both cases, the lack of oxygen- and nutrient-rich blood to the brain increases the risk of stroke, which can result in brain damage, death or other harm.

While carotid artery disease has traditionally been treated with surgery, less invasive interventional treatments using balloon angioplasty and stenting are increasingly used to clear blockages and restore blood flow in the carotid arteries. In these treatments, the physician inserts a sheath into an opening in an artery in the upper thigh or the arm and guides it through the arteries to the blockage in the neck. The sheath serves as a conduit for delivering catheters, stents and other artery-opening tools.

"Physicians consistently comment that gaining access through difficult anatomy is the hardest and most time-consuming part of carotid interventional procedures," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "The Strada Carotid Guiding Sheath is designed specifically to give physicians easier and faster access to blocked regions of the artery. Patients may benefit from reduced procedure times."

"The Strada Carotid Guiding Sheath is a versatile sheath that is particularly adaptable to the tortuous carotid anatomy," said Theodore Schreiber, M.D., specialist-in-chief, vice president of Cardiovascular Development and division chief of Clinical Cardiology, Detroit Medical Center. "It's a valuable addition to the tools available to physicians for the treatment of carotid artery disease with balloon angioplasty and stenting."

The Strada Carotid Guiding Sheath is engineered with five distinct transition zones to provide flexibility on the far, or distal, end of the sheath, and support on the near, or proximal, end of the sheath. Its construction provides excellent kink resistance for added confidence in navigating challenging anatomy. The Strada Carotid Guiding Sheath is available in 80 and 90 cm working lengths.

About St. Jude Medical

St. Jude Medical develops medical technology and services and focuses 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. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit http://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, 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 filed on February 27, 2008. 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