IRVINE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation today announced the U.S. launch of its LifeStent FlexStar and FlexStar XL stent delivery systems. FlexStar systems are designed to optimize the delivery of Edwards’ LifeStent nitinol self-expanding stents, which feature a triple-helix design and are currently approved for biliary indication in the United States.
“The FlexStar delivery system’s design allows the user increased deployment accuracy, taking advantage of LifeStent’s flexibility and radial strength,” said Keith Reisinger, Edwards’ corporate vice president and general manager, Vascular Business. “LifeStent FlexStar self-expanding stent delivery systems are designed for use in some of the most challenging cases.”
LifeStent FlexStar delivery systems offer clinicians multiple methods for stent deployment to accommodate individual preference. LifeStent FlexStar systems are now available in stent diameters from six millimeters to 10 millimeters and lengths up to 150 millimeters long. Edwards currently holds FDA 510(k) clearance for FlexStar systems to treat biliary obstructions, and an expanded European CE Mark including the treatment of peripheral vascular disease with stents up to 170 millimeters long.
The company will showcase its LifeStent FlexStar stent delivery systems this week at the Vascular Interventional Advances (VIVA) National Education Course for Peripheral Vascular Intervention being held September 26-29 at the Mandalay Bay Resort in Las Vegas, Nev.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, peripheral vascular disease and critical care technologies. The company’s global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. These forward looking statements include, but are not limited to, the clinical use and acceptance of the LifeStent FlexStar delivery systems. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict.
Actual results or experience could differ materially from the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by forward-looking statements are detailed in the company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2005.
Edwards Lifesciences, Edwards and FloTrac are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent FlexStar is a trademark of Edwards Lifesciences AG. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.
Edwards Lifesciences Corporation
CONTACT: Media, Jared B. Adams, +1-949-250-5070, or Investors, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
Web site: http://www.edwards.com//
