2.2 Million Americans Suffer From Atrial Fibrillation, Most Common Form of Cardiac Arrhythmias
IRVINE, Calif., Feb. 25 -- Edwards Lifesciences Corporation (NYSE: EW), a global leader in medical technologies to treat advanced cardiovascular disease, and the world's number-one heart valve company, announced today that it has entered into an alliance with PLC Medical Systems Inc. (Amex: PLC) to commercialize products for the surgical treatment of cardiac arrhythmias.
Under the exclusive, multi-year agreement, Edwards Lifesciences will transfer to PLC assets and technologies related to its Optimaze surgical laser ablation program. PLC will assume the responsibility of ongoing product development and manufacture of the Optimaze system and disposable components. Edwards will be the exclusive worldwide distributor of these products.
The arrangement builds upon Edwards' existing relationship with PLC as the exclusive distributor of PLC's TMR Heart Laser system for cardiac revascularization. ""The decision to expand the relationship with our partners at PLC was a natural one given the continuing success of our TMR partnership,"" said Michael A. Mussallem, Edwards' chairman and CEO. ""By combining the development activities of the Optimaze laser and disposable components within a focused organization that specializes in laser technologies, we believe we can further enhance the technology and accelerate the development of less invasive approaches to this therapy."" Edwards Lifesciences announced in December 2003 at its annual investor conference its intent to expand the development of its Optimaze program to include products that can be used on a beating heart. The company plans to begin market introduction of the redesigned surgical product line in the second half of 2004.
Edwards also announced that it has extended its existing distribution relationship with PLC for TMR products, including lengthening the term and improving the distribution margin for disposable products.
These transactions with PLC will not have a material financial impact to Edwards in 2004.
Laser Ablation Technology Treats Cardiac Arrhythmias
Cardiac arrhythmias, or heart rhythm disorders, are found in many patients suffering from various forms of cardiovascular disease and may result in more serious complications, including stroke. The most common and serious of these arrhythmias is atrial fibrillation, which causes the heart muscles to quiver, inhibiting the heart's ability to effectively pump blood. According to the American Heart Association, approximately 2.2 million Americans suffer from atrial fibrillation. As the incidence of cardiac arrhythmia is particularly high in patients undergoing heart valve replacement or repair surgery, therapies to treat cardiac arrhythmias complement Edwards' market-leading heart valve therapy franchise.
The Optimaze surgical laser ablation device utilizes a proprietary fiber optic and diffuser technology to give clinicians a flexible tool to create a rise in tissue temperature resulting in thermal ablation of the cardiac tissue. It is believed that the lesions created in this process block the conduction of errant electrical signals in the heart.
About Edwards Lifesciences
Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com .
Edwards Lifesciences, Edwards and Optimaze are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, Cosgrove-Edwards, Fogarty and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to the development, adoption and sales of the Optimaze cardiac ablation technology, and more generally timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and European Union, technological advances in the medical field, product demand and market acceptance, the effect of changing economic conditions, the impact of foreign exchange, 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 are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Contact Information :
Media, Barry R. Liden, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation