SAPIEN 3 Valve Demonstrates Low Mortality, Excellent 30-Day Outcomes In High- And Intermediate-Risk Patients

SAN DIEGO, March 15, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that 30-day outcomes for high- and intermediate-risk patients treated with the SAPIEN 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation.  This first report of SAPIEN 3 data in the United States, and first report on intermediate risk transcatheter aortic valve replacement (TAVR) patients, was presented as part of the late-breaking clinical trials at the American College of Cardiology's (ACC) 64^th Annual Scientific Session in San Diego.

"These results of more than 1,600 patients treated with the SAPIEN 3 valve demonstrate the most significant progress in the development of TAVR and the SAPIEN family of valves since the first PARTNER study was initiated in 2007," said Susheel Kodali, M.D., director, Heart Valve Program, at NewYork-Presbyterian/Columbia University Medical Center and assistant professor of medicine at the Columbia University College of Physicians and Surgeons.  Kodali is the co-principal investigator for the SAPIEN 3 studies.  "With average ages in the 80s, the high-risk and intermediate-risk patients in the study had strikingly low mortality rates of 2.2 and 1.1, respectively, despite predicted 30-day mortality that was much higher.  Additionally, the rates of significant paravalvular leaks were low in both cohorts – 3.0 for high-risk and 4.2 for intermediate – which represented meaningful improvements over prior studies with earlier generation devices."

The SAPIEN 3 high-risk cohort enrolled 583 patients at 29 U.S. sites; the intermediate risk cohort enrolled 1,076 patients at 51 U.S. sites.  Both studies were single-arm, non-randomized cohorts of the PARTNER II Trial.  Important clinical measures from the studies are presented in the table below. 

The SAPIEN 3 valve is Edwards' most advanced transcatheter aortic valve, and can be delivered through a low-profile 14 French expandable sheath (eSheath).  It also has an outer skirt – a cuff of fabric surrounding the bottom of the frame – to provide a seal to minimize paravalvular leak. The SAPIEN 3 valve can be implanted via the transfemoral approach through an incision in the leg, as well as alternative access approaches.

The SAPIEN 3 valve was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis.  It is not approved for the treatment of intermediate risk patients in Europe. The valve is an investigational device not yet available commercially in the United States. 

Clinical Outcomes at 30 Days with the SAPIEN 3 Valve (As-Treated)

Financial Outlook

As previously communicated, Edwards continues to plan for U.S. regulatory approval and launch of SAPIEN 3 early in 2016.  The company is not updating its sales and earnings per share guidance for 2015.  Edwards' projected 2015 diluted earnings per share of $4.00-4.30, excluding special items, reflects the expected reduction in reported sales due to changes in currency exchange rates, mitigated by currency hedge contracts and the benefit of the company's natural hedges.  If currencies remain at current levels, most of the benefit of the currency hedge contracts would not recur in 2016. 

Edwards is conducting an analyst update on Sunday, March 15, 2015, at 6:30 pm. This event will be accessible via live webcast at http://ir.edwards.com/eventdetail.cfm?EventID=157556 and available for replay on the "Investor Relations" section of the Edwards web site.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring.  Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at 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, statements of Dr. Kodali, statements regarding the launch status, availability and benefits of SAPIEN 3, and financial guidance in the "Financial Outlook" section. 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. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated clinical outcomes after longer-term patient experience and follow-up, and unexpected regulatory actions, competitive activity, or quality or manufacturing issues. These factors 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, 2014. 

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, SAPIEN 3 and PARTNER are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Non-GAAP Financial Information       

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP financial measures.   Our projection for diluted earnings per share is provided on a non-GAAP (or "excluding special items") basis and excludes the gains and losses from special items such as significant investments, litigation, and business development transactions due to the inherent difficulty in forecasting such items.  The Company is not able to provide a reconciliation of these non-GAAP items, to expected reported results due to the unknown effect, timing and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives. Management does not consider the excluded items or adjustments as part of day-to-day business or reflective of the core operational activities of the Company as they result from transactions outside the ordinary course of business.  

Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance.  These non-GAAP financial measures are used in addition to and in conjunction with results presented in accordance with GAAP and reflect an additional way of viewing aspects of the Company's core operations that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the Company's business.  Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.

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