IRVINE, Calif., June 13, 2005 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in heart valve technologies, announced today that it is delaying enrollment in its percutaneous aortic heart valve clinical feasibility trials in the U.S. in order to incorporate a new delivery system being evaluated in Canada.
The company took this voluntary action after some U.S. antegrade cases demonstrated a greater degree of clinical complexity and adverse outcomes when compared to results of a Canadian study, where cases are being performed with a new retrograde delivery system. Data presented at the 2005 Paris Course on Revascularization in May indicated that the company's custom retrograde delivery system resulted in positive clinical outcomes.
"We recently have completed a number of procedural refinements, including the development of a simpler and more direct retrograde delivery approach, which has led to more favorable clinical success rates and fewer complications," said Stanton J. Rowe, Edwards' corporate vice president, Percutaneous Valve Interventions. "Until we gain regulatory approval to allow this option in our trials, we have temporarily suspended U.S. patient enrollment."
Edwards has notified the U.S. Food and Drug Administration of its plans, and simultaneously is working to obtain approvals for this delivery approach. The company believes it will be able to resume its feasibility trial later this year. Previously, Edwards had expected to complete the trial's initial feasibility phase by the end of 2005. Today's announcement is not expected to have a material financial impact to Edwards Lifesciences. Further, company management expressed comfort with the First Call mean EPS estimate for the second quarter of 2005, and reiterated its EPS guidance of $1.90 to $1.95 for the full year.
"We remain confident about the potential of percutaneous heart valve therapies, which offer hope to thousands of patients worldwide who are not good candidates for conventional open-heart valve replacement surgery and face limited options," Rowe said. "At the same time, this is breakthrough medical therapy, and we want to ensure that we provide this technology in a responsible way to patients suffering from debilitating aortic valve stenosis."
About Percutaneous heart Valve Replacement
The Cribier-Edwards percutaneous aortic heart valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow). Percutaneous heart valve replacement can be performed under local anesthesia without opening the chest or stopping the heart. In a percutaneous heart valve procedure, the device is threaded through the patient's circulatory system via a catheter to the aortic valve from either of two directions. The antegrade approach involves crossing the patient's septum and mitral valve to reach their native aortic valve. The retrograde approach involves delivering the device directly to the aortic valve through the patient's main artery.
Conference Call and Webcast Information
Edwards Lifesciences will be hosting a conference call for investors today at 5:30 p.m. EDT to discuss today's announcement. To participate in the conference call, dial (877) 407-8037 or (201) 689-8037. For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using account number 2995 and conference number 157440. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards' web site at www.edwards.com or www.edwards.com/InvestorRelations/Pages/EventCalendar.aspx.
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 opportunities 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, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com/
This news release includes forward-looking statements that involve risks and uncertainties including those related to the incorporation of a new delivery system in the U.S. feasibility study; the receipt of regulatory approval for the retrograde delivery system; the resumption of the U.S. feasibility trials later this year; the potential of percutaneous heart valve therapies to treat thousands of patients worldwide; the financial impact of this development to the company; management's comfort with the First Call mean EPS estimate for the second quarter of 2005, and its EPS guidance of $1.90 to $1.95 for the full year; and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Actual results or experience could differ materially from that expressed or implied by forward-looking statements.
Edwards Lifesciences, Edwards and Cribier-Edwards are trademarks of Edwards Lifesciences Corporation. 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 is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.