Edwards Lifesciences Corporation is focused on technologies that treat structural
heart disease and critically ill patients. A pioneer in the development and commercialization
of heart valve products, Edwards Lifesciences is the world's leading manufacturer
of tissue heart valves and repair products used to replace or repair a patient's
diseased or defective heart valve. The Company is also a global leader in hemodynamic
monitoring systems used to measure a patient's cardiovascular function in the
hospital setting.
Cardiovascular disease is the number-one cause of death in the world, and
is the top disease in terms of health care spending in nearly every country.
Cardiovascular disease is progressive in that it tends to worsen over time and
often affects an individual's entire circulatory system.
The products and technologies provided by Edwards Lifesciences to treat advanced
cardiovascular disease or critically ill patients are categorized into three
main areas: Surgical Heart Valve Therapy, which combines surgical heart valves
and Cardiac Surgery Systems; Transcatheter Heart Valves; and Critical Care,
which includes Vascular.
Patients undergoing surgical treatment for cardiovascular disease may be treated
using a variety of Edwards Lifesciences' products and technologies. For example,
an individual with a heart valve disorder may have a faulty valve. A clinician
may elect to remove the valve and replace it with one of Edwards Lifesciences'
bioprosthetic surgical tissue heart valves, surgically re-shape and repair the
faulty valve with an Edwards Lifesciences annuloplasty ring, or deploy an Edwards
Lifesciences transcatheter valve via a minimally invasive catheter-based system.
If a patient undergoes open-heart surgery, Edwards Lifesciences' Cardiac Surgery
Systems products may be used while the patient's heart and lung functions are
being bypassed, or used during minimally invasive valve surgery. Virtually all
high-risk patients in the operating room or intensive care unit are candidates
for having their cardiac function monitored by Edwards Lifesciences' Critical
Care products. If the circulatory problems are in the limbs rather than in the
heart, the patient's procedure may involve some of Edwards Lifesciences' Vascular
products, which include various types of balloon-tipped catheters that are used
to remove blood clots from diseased blood vessels.
Edwards Lifesciences' principal executive offices are located at One Edwards
Way, Irvine, California 92614. The telephone number at that address is (949)
250-2500.
Competition
The medical device industry is highly competitive. Edwards Lifesciences competes
with many companies, ranging from small start-up enterprises to companies that
are larger with broader product offerings than Edwards Lifesciences. Furthermore,
new product development and technological change characterize the areas in which
Edwards Lifesciences competes. The present or future products of Edwards Lifesciences
could be rendered obsolete or uneconomical as a result of technological advances
by one or more of Edwards Lifesciences' present or future competitors or by
other therapies, including drug therapies. Edwards Lifesciences must continue
to develop and acquire new products and technologies to remain competitive in
the cardiovascular medical device industry. Edwards Lifesciences believes that
it competes primarily on the basis of clinical superiority and innovative features
that enhance patient benefit, product reliability, performance, customer and
sales support, and cost-effectiveness.
The cardiovascular segment of the medical device industry is dynamic and subject
to significant change due to cost-of-care considerations, regulatory reform,
industry and customer consolidation, and evolving patient needs. The ability
to provide products and technologies that demonstrate value and improve clinical
outcomes is becoming increasingly important for medical device manufacturers.
Edwards Lifesciences believes that it is globally one of the leading competitors
in each of its major product lines. The Company's products and technologies
face substantial competition from a number of companies including divisions
of companies much larger than Edwards Lifesciences and smaller companies that
compete in specific product lines or certain geographies. In Surgical and Transcatheter
Heart Valve therapies, the Company's primary competitors include St. Jude Medical,
Inc., Medtronic, Inc. and Sorin Group. In Critical Care, Edwards Lifesciences
competes primarily with a variety of companies in specific product lines including
ICU Medical, Inc., PULSION Medical Systems AG and LiDCO Group PLC.
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