IRVINE, Calif., Nov. 29 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in heart valve technologies, announced today the successful completion of the first minimal-access, beating-heart surgical procedure for replacing a patient's aortic heart valve. Edwards is planning on developing the Ascendra aortic heart valve replacement system as an additional option for valve surgery.
A medical team from St. Paul's Hospital in Vancouver, British Columbia, used Edwards' proprietary Cribier-Edwards percutaneous heart valve to perform Trans-Apical Placement (TAP), a beating-heart procedure in which a sutureless, stent-mounted aortic valve was delivered through a mini-incision between the ribs. The first TAP procedure was performed at St. Paul's by Dr. Samuel Lichtenstein, director of cardiovascular surgery, and Dr. John Webb, director of interventional cardiology, earlier this month.
"The valve's innovative, sutureless design enabled us to perform aortic valve replacement surgery on a beating heart without cardiopulmonary bypass, offering patients an option that should reduce the recovery time and complications associated with traditional, open-heart surgery," said Dr. Lichtenstein. "We believe clinical collaboration is key to ensuring optimal patient care, and Dr. Webb's experience with the percutaneous technology enabled us to successfully complete this ground-breaking procedure."
"Early results from the Cribier-Edwards percutaneous heart valve trials have reinforced Edwards Lifesciences' enthusiasm for this technology, and led us to explore additional approaches for a greater number of patients while we continue our clinical studies," said Stanton J. Rowe, Edwards' corporate vice president, Percutaneous Valve Interventions. Rowe added that more than 75 patients have received the Cribier-Edwards percutaneous aortic heart valve, which is delivered through the patient's circulatory system via a catheter.
Surgeons Develop New Procedure Using Cribier-Edwards Valve
In the TAP procedure, clinicians utilized the Cribier-Edwards percutaneous heart valve technology, which integrates a balloon-expandable stent with an aortic replacement tissue heart valve. The balloon-mounted valve was compressed to the approximate diameter of a pencil, then inserted through a small incision between the ribs and delivered through the bottom apex of the heart, where it was deployed inside of the native valve. While traditional aortic valve replacement surgery requires opening the patient's chest, stopping their heart, and managing their circulation on cardiopulmonary bypass for at least an hour, the first TAP procedure was completed on a beating heart less than 30 minutes after the surgical mini-incision was made.
The TAP procedure for utilization with the Edwards Ascendra valve system was developed in partnership with surgical teams led by Dr. Michael Mack of Medical City, Dallas; Dr. Friedrich Mohr of Leipzig, Germany, and Dr. Gerhardt Wimmer-Greinecker of Frankfurt, Germany.
"Edwards has been working with surgeons to identify how to best adapt our percutaneous aortic heart valve technology to provide patients with a wide range of complementary options," said Anita B. Bessler, Edwards' corporate vice president of Global Franchise Management. "We are developing the Ascendra aortic valve replacement system to enable implantation of the Cribier-Edwards percutaneous heart valve specifically in the TAP procedure."
Edwards' Ascendra system is not yet commercially available, and the company plans to continue to evaluate its feasibility in European and Canadian studies in 2006. Results from the feasibility studies will determine timelines for a future pivotal study intended to achieve commercial clearance in key global markets.
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.
Ascendra and Cribier-Edwards 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 is a trademark of Edwards Lifesciences AG and is 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 results from the clinical use of, and feasibility studies for, the Ascendra aortic valve replacement system 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.
Edwards Lifesciences CorporationCONTACT: Media: Barry R. Liden, +1-949-250-5070, or Investors:+1-949-250-6826, both of Edwards Lifesciences
Web site: http://www.edwards.com/
