IRVINE, Calif., April 18, 2008 -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that yesterday the first patients were treated in a United States feasibility study using the Edwards SAPIEN transcatheter heart valve in addressing a congenital condition in which the valve between the right ventricle and the pulmonary artery is nonfunctional.
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today," saidZiyad M. Hijazi, M.D., M.P.H., director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago, and a paid consultant to Edwards Lifesciences. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves. This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a failing pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities."
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.
In this transcatheter valve replacement procedure, the Edwards SAPIEN bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.
"Edwards is proud to have the opportunity to address this critical unmet patient need and to offer these patients a far less traumatic treatment option," saidLarry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "This therapy leverages all of our Edwards SAPIEN valve platform technologies to help these congenital patients via a minimally-invasive treatment alternative." Edwards' physician partners performed the first U.S. transcatheter pulmonic case on a compassionate basis in December 2005. All of the compassionate cases have been successful.
The Edwards SAPIEN transcatheter heart valve is also currently being studied in the PARTNER (Placement of AoRTic traNscathetER valves) U.S. pivotal trial for the treatment of patients with severe aortic heart valve stenosis (a narrowing of the aortic valve that restricts blood flow), who are considered to be high risk for conventional open-heart valve replacement surgery.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna 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 Exchange Act of 1934. These forward-looking statements include, but are not limited to, the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter technologies. 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.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the 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, 2007.
Edwards, Edwards SAPIEN and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.