SOURCE: Edwards Lifesciences
PHILADELPHIA, PA--(Marketwire - May 11, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that interim data from a multi-center European prospective study of the investigational EDWARDS INTUITY Valve System showed promising results for patients undergoing surgical aortic valve replacement (AVR). The results generally reflect those found in traditional open-heart surgery, but demonstrate reduced cross-clamp and bypass times as compared to those of The Society of Thoracic Surgeons' (STS) National Database, according to a presentation today during the Emerging Technologies and Techniques Forum at the American Association for Thoracic Surgery's 91st Annual Meeting in Philadelphia.
These data are from the TRITON clinical study, evaluating the feasibility, safety and performance of the EDWARDS INTUITY Valve System, which is based on Edwards' market-leading pericardial tissue valve design. These data are intended to support the company's CE Mark application for European commercial approval.
In this first clinical experience, surgeons at five centers achieved a technical success rate (the valve was implanted as intended) of 94 percent. A total of 90 patients with severe, symptomatic aortic stenosis or stenosis-insufficiency received the EDWARDS INTUITY Valve System in an isolated AVR or AVR with a concomitant procedure. For the isolated AVR procedures, mean aortic cross-clamp times were reduced by 43 percent, and mean bypass times by 41 percent, compared to the STS National Database. Comparable data for concomitant procedures are not available. Published studies indicate that a shorter duration of aortic cross-clamping is associated with a reduction in mortality and morbidity after AVR.
"We are encouraged by these interim results and the promise of this new technology. Implantation using the EDWARDS INTUITY Valve System may enable smaller incisions for isolated valve cases, which we believe could result in clinically significant benefits for patients," said Prof. Axel Haverich, M.D., head of the Department of Cardiothoracic Transplantation and Vascular Surgery at Hannover Medical School in Germany and lead investigator of the study. "At three months' follow-up, these patients demonstrated sustained clinical status improvement and the valve provided excellent hemodynamic performance."
The EDWARDS INTUITY Valve System leverages the proven design of Edwards' pericardial valve platform, which features aortic valves with nearly 30 years of clinical experience, and includes an innovative balloon-expandable frame. The valve system enables rapid valve deployment and is designed to reduce procedural complexity. It is an investigational device limited by law to investigational use only, and is not yet available commercially in any country.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at 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 Exchange Act of 1934. These forward-looking statements include, but are not limited to, Prof. Haverich's statements and statements regarding potential clinical results and benefits of the EDWARDS INTUITY Valve System, the potential for reduced mortality and morbidity, and the potential timing and results of regulatory submissions and approvals for the valve. 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. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected delays or changes in the regulatory submission and approval processes, unexpected results following expanded clinical experience and market developments. These and other factors 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo and EDWARDS INTUITY are trademarks of Edwards Lifesciences Corporation.