IRVINE, CA, January 25, 2010 -- Edwards Lifesciences Corporation (NYSE: EW), the
world leader in the science of heart valves and hemodynamic monitoring, has
completed first in man procedures and initiated a feasibility study in
Europe for a novel minimally invasive aortic valve surgery system, known as
Project Odyssey. The system is part of Edwards' strategy to marry its
expertise in heart valves with innovations in delivery to improve the valve
surgery experience for both surgeons and their patients. The company will
feature its full line of valve replacement and repair products at the 46th
annual meeting of the Society of Thoracic Surgeons (STS) in Fort Lauderdale
this week.
"The investigational Odyssey aortic valve replacement system is designed to
enable surgeons to rapidly deploy a heart valve that offers excellent
hemodynamics and proven durability, without requiring a traditional sutured
approach. This is a great step forward for patients who are not high risk
enough to qualify for transapical valve replacement, yet are seeking a
less-invasive option," said Prof. Axel Haverich, M.D., whose team performed
the first successful implants of the new system. Haverich is head of the
Department of Cardiothoracic Transplantation and Vascular Surgery at
Hannover Medical School in Germany and provides paid consulting services to
Edwards Lifesciences for research and development of products and services
for heart valve replacement.
The Project Odyssey system leverages the design of the Carpentier-Edwards
PERIMOUNT Magna Ease tissue heart valve to create a new valve platform with
an innovative delivery and attachment system. It is designed to enable a
faster procedure, shorter patient time on cardiopulmonary bypass and a
smaller incision. The feasibility study for Project Odyssey, TRITON, is
now is actively enrolling at several European sites.
"Project Odyssey is an exciting development that enables Edwards to take a
substantial leap forward in extending minimally invasive options to
patients with aortic valve disease," said Donald E. Bobo, Jr., Edwards'
corporate vice president, heart valve therapy. "By combining important
features of our market-leading pericardial tissue valves and learnings from
our transcatheter valve program, we are creating products designed to offer
a better experience for valve patients and their surgeons."
At STS, Edwards is introducing new minimally invasive accessories for use
with its Carpentier-Edwards Physio II ring for mitral valve repair, in
addition to providing education about aortic procedural techniques at an
evening symposium, "Managing the Complexity of Aortic Valve Disease:
Leading Approaches and Perspectives," on Jan. 25. William Ryan, M.D., of
the Heart Hospital Baylor Plano in Plano, Texas, will lecture on minimally
invasive approaches for aortic valve replacement, while Daniel Doyle, M.D.,
of the Quebec Heart & Lung Institute in Quebec City, Quebec, will discuss
the latest outcomes in transcatheter aortic valve implantation using the
Edwards SAPIEN valve with the Ascendra transapical delivery system.
The Edwards Lifesciences booth #908 at STS includes interactive stations
for tissue heart valves and repair products, cardiac surgery systems
demonstrations and simulators featuring its Edwards SAPIEN transcatheter
aortic heart valve. The Edwards SAPIEN valve is approved for commercial
sale in Europe. In the United States, it is an investigational device being
studied as part of the PARTNER Trial.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves
and hemodynamic monitoring, with more than five decades of experience in
partnering with clinicians to develop life-saving innovations.
Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular
disease with its market-leading heart valve therapies, and critical care
and vascular technologies, which are sold in approximately 100 countries.
The company's global brands include Carpentier-Edwards, Cosgrove-Edwards,
Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional
company information can be found at www.edwards.com.
Edwards, Carpentier-Edwards, Magna Ease and Physio II are trademarks of
Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E
logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN,
FloTrac, Fogarty, PERIMOUNT, PERIMOUNT Magna and Swan-Ganz are trademarks
of Edwards Lifesciences Corporation and are registered in the United States
Patent and Trademark Office.
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