Healthcare Industry News: Millennium
News Release - February 21, 2007
St. Jude Medical Receives FDA Clearance for Venture Catheter with New Delivery PlatformCatheter Provides Exceptional Control in Treating Hard-to-Reach Areas of Coronary Anatomy
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance for the Venture(TM) Wire Control Catheter on a rapid exchange delivery platform, a delivery design that accommodates shorter guidewires and may result in quicker, easier coronary procedures.
In the United States, more than 1 million catheter-based coronary procedures are performed each year.(1) In these procedures, a guidewire is threaded through the patient's femoral artery and positioned across a coronary blockage prior to the delivery of a device, such as a stent or a balloon, to hold open a clogged vessel.
The Venture catheter is a unique catheter designed with a deflectable tip - a feature that allows interventional cardiologists to treat difficult-to-reach areas of the coronary anatomy. Capable of bending 90 degrees, the deflectable tip helps physicians with control and precision when navigating complex turns in the artery, and it provides guidewire support when attempting to access partially blocked vessels.
With approval of the rapid exchange delivery platform, the Venture catheter now accommodates guidewires of any length, including the shorter guidewires most commonly used in interventional procedures. The Venture catheter was originally approved in the United States and Europe in 2005 with an over-the-wire delivery platform.
"The Venture catheter on a rapid exchange platform helps place guidewires in branches of the coronary anatomy previously considered difficult or impossible to reach," said George J. Fazio, president of St. Jude Medical's Cardiovascular Division. "This catheter represents a significant technological advancement in access devices for cardiologists, which may result in reduced overall time and costs associated with these procedures."
The Venture catheter is part of a growing portfolio of products introduced by St. Jude Medical to enable new or more effective interventional therapies and to serve the unmet clinical needs of interventional cardiologists.
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 more than 11,000 people worldwide. For more information, please visit www.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 Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Reports on Form 10-Q filed on August 7, 2006 (see Item 1A on page 32) and November 7, 2006 (see pages 31-32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
(1) Millennium Research Group, US Markets for Interventional Cardiology, 2005
Source: St. Jude Medical
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