This report contains 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. The Company intends the forward-looking statements contained in this report to be covered by the safe harbor provisions of such Acts. All statements other than statements of historical fact in this report or referred to or incorporated by reference into this report are "forward-looking statements" for purposes of these sections. These statements include, among other things, any predictions of earnings, revenues, expenses or other financial items, plans or expectations with respect to development activities, clinical trials, or regulatory approvals, any statements of plans, strategies, and objectives of management for future operations, any statements concerning the Company's future operations, financial conditions and prospects, and any statement of assumptions underlying any of the foregoing. These statements can sometimes be identified by the use of the forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "continue," "seek," "pro forma," "forecast," "intend" or other similar words or expressions or the negative thereof. Investors are cautioned not to unduly rely on such forward-looking statements. These forward-looking statements are subject to substantial risks and uncertainties that could cause the Company's future business, financial condition, results of operations, or performance to differ materially from the Company's historical results or those expressed in any forward-looking statements contained in this report. Investors should carefully review the information contained in, or incorporated by reference into, the Company's annual report on Form 10-K for the year ended December 31, 2008 for a description of certain of these risks and uncertainties.

Overview

Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company") is a global leader in products and technologies designed to treat advanced cardiovascular disease. The Company is focused specifically on technologies that treat structural heart disease and critically ill patients.

The products and technologies provided by Edwards Lifesciences are categorized into four main areas: Heart Valve Therapy; Critical Care; Cardiac Surgery Systems; and Vascular.

Edwards Lifesciences' Heart Valve Therapy portfolio is comprised of tissue heart valves and heart valve repair products. 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. In the Critical Care area, Edwards Lifesciences is a world leader in hemodynamic monitoring equipment used to measure a patient's cardiovascular function and in disposable pressure transducers. Through the end of August 2009, Edwards Lifesciences provided central venous access products for fluid and drug delivery ("hemofiltration product line"). The Company sold the hemofiltration product line effective September 1, 2009. The Company's Cardiac Surgery Systems portfolio comprises a diverse line of products for use during cardiac surgery including cannula, EMBOL-X technologies, and other disposable products used during cardiopulmonary bypass procedures. Cardiac Surgery Systems also includes the Company's minimally invasive surgery ("MIS") product line. Edwards Lifesciences' Vascular portfolio includes a line of balloon catheter-based products, surgical clips and inserts, and artificial implantable grafts. Through early 2008, Edwards Lifesciences manufactured and sold LifeStent balloon-expandable and self-expanding non-coronary stents. The Company sold the LifeStent product line in January 2008, but continued to manufacture these products for the buyer until September 2009 when manufacturing was transferred to the buyer.

The healthcare marketplace continues to be competitive with strong global and local competitors. The Company competes with many companies, ranging from small start-up enterprises to companies that are larger and more established than Edwards Lifesciences with access to significant financial resources. Furthermore, rapid product development and technological change characterize the market

in which the Company competes. Global demand for healthcare is increasing as the population ages. There is mounting pressure to contain healthcare costs in the face of this increasing demand, which has resulted in pricing and market share pressures. The cardiovascular segment of the medical device industry is dynamic, and technology, cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient needs are expected to continue to drive change.

Recently Adopted Accounting Standards

In September 2006, the Financial Accounting Standards Board ("FASB") issued new accounting guidance on fair value measurements. This new guidance defined fair value, established a framework for measuring fair value, and expanded disclosures about fair value measurements. In February 2008, the FASB delayed the effective date of this guidance for all non-financial assets and non-financial liabilities, except for those items that are recognized or disclosed at fair value in the financial statements on a recurring basis, until fiscal years beginning after November 15, 2008. The Company's adoption of this guidance, as it applies to those non-financial assets and liabilities affected by the one-year delay, did not have a material impact on the Company's consolidated financial statements.

In December 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force ("EITF") on accounting for collaborative arrangements. This new accounting guidance defined collaborative arrangements and established reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties. The guidance also established the appropriate income statement presentation and classification for joint operating activities and payments between participants, as well as the sufficiency of the disclosures related to these arrangements. The guidance was effective for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Retrospective application to all prior periods presented was required for all collaborative arrangements existing as of the effective date. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In December 2007, the FASB issued new accounting guidance on business combinations which established principles and requirements for how the acquirer of a business recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree. This guidance also established principles and requirements for recognizing and measuring goodwill acquired in the business combination and determined what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. Among other requirements, the guidance expanded the definition of a business combination, required acquisitions to be accounted for at fair value, and required transaction costs and restructuring charges to be expensed. The guidance was effective for fiscal years beginning on or after December 15, 2008 and will impact the Company if it is involved in a business combination.

In March 2008, the FASB issued new accounting guidance on disclosures about derivative instruments and hedging activities. The new guidance required enhanced disclosures about an entity's derivative instruments and hedging activities, including (a) how and why an entity uses derivative instruments,
(b) how derivative instruments and related hedged items are accounted for and
(c) how derivative instruments and related hedged items affect an entity's financial position, financial performance, and cash flows. The guidance was effective for fiscal years and interim periods beginning after November 15, 2008. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In April 2008, the FASB issued new accounting guidance that amended the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset. The new guidance applied to intangible assets that are acquired individually or with a group of other assets acquired in business combinations and asset acquisitions and required

expanded disclosure related to the determination of intangible asset useful lives. The guidance was effective for fiscal years beginning after December 15, 2008. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In November 2008, the FASB ratified the consensus reached by the EITF which clarified the accounting for certain transactions and impairment considerations involving equity method investments. This new accounting guidance was effective for fiscal years beginning after December 15, 2008, with early adoption prohibited. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In November 2008, the FASB ratified the consensus reached by the EITF which clarified the accounting for certain separately identifiable intangible assets which an acquirer does not intend to actively use but intends to hold to prevent its competitors from obtaining access to them. The new guidance required an acquirer in a business combination to account for a defensive intangible asset as a separate unit of accounting which should be amortized to expense over a period the asset diminishes in value. The guidance was effective for fiscal years beginning after December 15, 2008, with early adoption prohibited. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In April 2009, the FASB issued new accounting guidance which required that assets acquired and liabilities assumed in a business combination that arise from contingencies be recognized at fair value if fair value can be reasonably determined. If the fair value cannot be reasonably determined, then the assets and liabilities should be recognized at the amount that would be recognized in accordance with the FASB Accounting Standards Codification ("ASC") Topic 450, "Contingencies." The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

In April 2009, the FASB issued new accounting guidance on estimating fair value when the volume and level of activity for the asset or liability have significantly decreased, and identifying circumstances that indicate a transaction is not orderly. The guidance was effective for interim and annual reporting periods ending after June 15, 2009. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In April 2009, the FASB issued new accounting guidance that amended the other-than-temporary impairment guidance related to debt securities and expanded and increased the frequency of existing disclosures about debt and equity securities and other-than-temporary impairments for debt and equity securities. The new guidance was effective for interim and annual reporting periods ending after June 15, 2009. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In April 2009, the FASB issued new accounting guidance which required disclosures about the fair value of financial instruments for interim reporting periods of publicly traded companies as well as in annual financial statements. The guidance was effective for interim reporting periods ending after June 15, 2009. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In May 2009, the FASB issued new accounting guidance that established general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. The new guidance required the disclosure of the date through which an entity has evaluated subsequent events and whether that date represents the date the financial statements were issued or were available to be issued. The new guidance was effective for interim or annual financial periods ending after June 15, 2009. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.

In June 2009, the FASB issued a new accounting standard establishing the ASC as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities

in preparation of financial statements in conformity with generally accepted accounting principles ("GAAP"). Rules and interpretive releases of the Securities and Exchange Commission ("SEC") under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants. The new accounting standard was effective for financial statements issued for interim and annual periods ending after September 15, 2009. The ASC does not change GAAP and did not have a material impact on the Company's consolidated financial statements.

New Accounting Standards Not Yet Adopted

In June 2009, the FASB issued an amendment to the accounting and disclosure requirements for the consolidation of variable interest entities ("VIEs"). This new accounting guidance eliminates the exemption for qualifying special purpose entities and establishes a new approach for determining the primary beneficiary of a VIE based on whether the entity (a) has the power to direct the activities of the VIE that most significantly impact the entity's economic performance and
(b) has the obligation to absorb losses of the entity or the right to receive benefits from the entity that could potentially be significant to the VIE. The guidance requires an ongoing reconsideration of the primary beneficiary, and amends the events that trigger a reassessment of whether an entity is a VIE. Enhanced disclosures are also required to provide information about an enterprise's involvement in a VIE. The guidance is effective for the first annual reporting period beginning after November 15, 2009, for interim periods within that first annual reporting period, and for interim and annual reporting periods thereafter. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.

In August 2009, the FASB issued an amendment to ASC 820, "Fair Value Measurements and Disclosures," to clarify how an entity should measure the fair value of liabilities when a quoted price in an active market for the identical liability is not available. The guidance is effective for the first reporting period beginning after its issuance. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.

In October 2009, the FASB issued an amendment to ASC 605, "Revenue Recognition," to require companies to allocate revenue in arrangements involving multiple deliverables based on estimated selling price in the absence of vendor-specific objective evidence or third-party evidence of selling price for the deliverables. ASC 605 was also amended to eliminate the requirement that all undelivered elements must have objective and reliable evidence of fair value before a company can recognize the portion of the overall arrangement fee that is attributable to items that have already been delivered. The guidance is effective for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.

Results of Operations

     Net Sales Trends

    The following is a summary of United States and international net sales
(dollars in millions):

                        Three Months Ended                               Nine Months Ended
                           September 30,                   Percent         September 30,                   Percent
                        2009          2008      Change     Change       2009          2008      Change     Change
United States           $ 137.0       $ 135.6    $  1.4         1.0 %   $ 415.4       $ 410.8    $  4.6         1.1 %
International             188.7         168.0      20.7        12.3 %     559.3         517.2      42.1         8.1 %

    Total net sales     $ 325.7       $ 303.6    $ 22.1         7.3 %   $ 974.7       $ 928.0    $ 46.7         5.0 %

In the United States, the $1.4 million and $4.6 million increases in net sales for the three and nine months ended September 30, 2009, respectively, were due primarily to:

º •
º Heart Valve Therapy products, which increased net sales by $8.0 million and $21.4 million, respectively, driven primarily by the Carpentier-Edwards PERIMOUNT Magna Ease and Magna with ThermaFix valves, and the Carpentier-Edwards Physio II ring, which was launched in the first quarter of 2009;

partially offset by:

º •
º the divestiture of the LifeStent product line in mid-January 2008, which decreased net sales by $7.4 million and $18.1 million, respectively. Sales after the divestiture resulted from the on-going manufacturing requirements of the sale agreement, which continued until the transfer of manufacturing to the buyer in September 2009.

International net sales increased $20.7 million and $42.1 million for the three and nine months ended September 30, 2009, respectively, due primarily to:

º •
º Heart Valve Therapy products, which increased net sales by $19.1 million and $63.9 million, respectively, driven primarily by the Edwards SAPIEN transcatheter heart valve, the Carpentier-Edwards PERIMOUNT Magna Ease valve, and the Magna aortic valve in Japan; and

º •
º FloTrac systems, which increased net sales by $2.3 million and $7.2 million, respectively;

partially offset by:

º •
º foreign currency exchange rate fluctuations, which decreased net sales by $3.4 million and $31.8 million, respectively, due primarily to the weakening of the Euro against the United States dollar.

The impact of foreign currency exchange rate fluctuations on net sales is not necessarily indicative of the impact on net income due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and operating costs and the Company's hedging activities. For more information see Item 3, "Quantitative and Qualitative Disclosures About Market Risk."

     Net Sales by Product Line

    The following table is a summary of net sales by product line (dollars in
millions):


                        Three Months                               Nine Months
                            Ended                                     Ended
                        September 30,               Percent       September 30,               Percent
                       2009      2008     Change     Change      2009      2008     Change     Change
 Heart Valve
 Therapy              $ 174.1   $ 148.4    $ 25.7       17.3 %  $ 526.6   $ 457.7   $  68.9       15.1 %
 Critical Care          114.2     110.3       3.9        3.5 %    331.7     333.6      (1.9 )     (0.6 )%
 Cardiac Surgery
 Systems                 22.3      21.4       0.9        4.2 %     68.9      66.3       2.6        3.9 %
 Vascular                15.1      23.5      (8.4 )    (35.7 )%    47.5      70.4     (22.9 )    (32.5 )%

     Total net
     sales            $ 325.7   $ 303.6    $ 22.1        7.3 %  $ 974.7   $ 928.0   $  46.7        5.0 %

Net sales of Heart Valve Therapy products for the three and nine months ended September 30, 2009 increased by $25.7 million and $68.9 million, respectively, due primarily to:

º •
º the Edwards SAPIEN transcatheter heart valve, which increased net sales by $13.6 million and $46.3 million, respectively; and

º •
º pericardial tissue valves, which increased net sales by $11.3 million and $33.0 million, respectively, primarily as a result of the Carpentier-Edwards PERIMOUNT Magna Ease valve, the Magna with ThermaFix mitral valve, and the Magna aortic valve in Japan;

partially offset by

º •
º foreign currency exchange rate fluctuations, which decreased net sales by $2.1 million and $17.4 million, respectively, due primarily to the weakening of the Euro against the United States dollar.

The Company expects that its SAPIEN transcatheter heart valve will continue to be a strong contributor to 2009 sales. The Company received Food and Drug Administration ("FDA") approval for its Magna Ease aortic valve in May 2009. The Magna Ease valve is designed for easier implantation and has the potential for leadership in the largest segment of surgical valve replacement. In July 2009, the Company received United States regulatory approval for its Magna Mitral valve, called the Magna Mitral Ease. The Magna Mitral Ease will extend the Magna platform by providing improved MIS capabilities and ease of implantation. The Company launched the Carpentier-Edwards Physio II ring in the United States and Europe during the first quarter of 2009, and received regulatory approval in Japan during the third quarter of 2009 and expects formal reimbursement approval in the fourth quarter of 2009. The Company expects this product to contribute to its growth in the repair segment. Physio II is the next generation repair product for the degenerative segment of mitral repair. In Japan, the Company received regulatory approval for its IMR ETlogix ring during the first quarter of 2009, and launched this product in Japan during the third quarter of 2009.

The $3.9 million increase and the $1.9 million decrease in net sales of Critical Care products for the three and nine months ended September 30, 2009, respectively, were due primarily to:

º •
º FloTrac systems, which increased net sales by $3.5 million and $9.5 million, respectively; and

º •
º core Critical Care products, which increased net sales by $2.9 million and $1.5 million, respectively, driven primarily by pressure monitoring products;

offset by:

º •
º foreign currency exchange rate fluctuations, which decreased net sales by $0.5 million and $10.0 million, respectively, due primarily to the weakening of the Euro against the United States dollar; and

º •
º hemofiltration products, which decreased net sales by $1.9 million and $2.3 million, respectively. The Company sold its hemofiltration product line effective September 1, 2009. For more information see "Special (Gains) Charges, net."

The Company expects worldwide FloTrac systems sales will continue to be a significant contributor to 2009 Critical Care sales growth, and that it will continue to expand the market for minimally invasive hemodynamic monitoring. During the first quarter of 2009, the Company launched a third generation algorithm enhancement for the FloTrac system that enhances its accuracy when used in patients with sepsis and other critical illnesses. In the fourth quarter of 2009, the Company is planning a limited launch of a substantial upgrade designed to strengthen the FloTrac system's applicability in the medical intensive care unit. In addition, the Company anticipates launching a new hardware platform in the fourth quarter of 2009 with a simpler, more intuitive informational display, and expects to ultimately consolidate all parameters into one new hardware platform with a broad launch at the end of the first quarter of 2010.

During the fourth quarter of 2008, the Company entered into a collaboration agreement with DexCom, Inc. to develop products for continuously monitoring blood glucose levels in patients hospitalized for a variety of conditions. During the third quarter of 2009, the first of two clinical studies to validate performance and support regulatory approval was completed. In October 2009, the Company received CE Mark approval and anticipates beginning clinical evaluation of its first generation product before the end of 2009 in a limited number of European sites.

The $0.9 million and $2.6 million increases in net sales of Cardiac Surgery Systems products for the three and nine months ended September 30, 2009, respectively, were due primarily to MIS products, which increased net sales by $0.6 million and $3.7 million, respectively. Foreign currency exchange rate fluctuations decreased net sales by $0.4 million and $2.3 million, respectively.

The $8.4 million and $22.9 million decreases in net sales of Vascular products for the three and nine months ended September 30, 2009, respectively, were due primarily to reduced sales of the LifeStent product line which was divested in January 2008. Sales after the divestiture resulted from the on-going manufacturing requirements of the sale agreement, which continued until the transfer of manufacturing to the buyer in September 2009.

     Gross Profit

                                           Three Months                     Nine Months
                                               Ended                           Ended
                                           September 30,                   September 30,
                                    2009     2008      Change       2009     2008      Change
Gross profit as a percentage of
net sales                            69.8 %   65.4 %    4.4 pts.     69.5 %   65.4 %    4.1 pts.

The 4.4 and 4.1 percentage point increases in gross profit as a percentage of net sales for the three and nine months ended September 30, 2009, respectively, were driven by:

º •
º a 1.5 percentage point and a 1.3 percentage point increase in the United States gross profit as a percentage of net sales for the three and nine months ended September 30, 2009, respectively, due primarily to a more profitable product mix, primarily from reduced sales of LifeStent products under the manufacturing requirements of the LifeStent sale agreement;

º •
º a 1.3 percentage point increase in international gross profit as a percentage of net sales for both the three and nine months ended September 30, 2009 due to a more profitable product mix, primarily higher sales of Heart Valve Therapy products and FloTrac systems; and

º •
º the impact from the expiration of foreign currency hedging contracts.

. . .