SAN FRANCISCO, CA--(Marketwire - Mar 11, 2013) - Edwards Lifesciences Corporation (
"These three-year data from The PARTNER Trial strengthen the evidence that the SAPIEN valve is a safe and less-invasive alternative for those patients who need valve replacement, but are at high surgical risk," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "The availability of the SAPIEN valve encourages the many untreated patients to work with a Heart Team to determine whether transcatheter valve replacement or surgery is the right option for them."
At three years, all-cause mortality for patients treated with the Edwards SAPIEN transcatheter aortic valve replacement (TAVR) delivered via the femoral artery or a small incision between the ribs was statistically equivalent to that of patients who had received open-heart surgical aortic valve replacement (AVR). Symptom improvement and valve performance was similar in both groups and was maintained through the three years of patient follow-up. The incidence of stroke between TAVR and surgery patients was also comparable. (See table below for specific data points.)
The PARTNER Trial is the first randomized, controlled trial of a transcatheter aortic valve in the United States. The high-risk surgery cohort (Cohort A) of the trial enrolled between May 2007 and Sept. 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multi-disciplinary Heart Team and randomized to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery.
The Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012.
The PARTNER Trial, High-Risk Surgical Cohort (Cohort A)i
|Outcome||SAPIEN||Surgery||p value||SAPIEN||Surgery||p value||SAPIEN||Surgery||p value|
|All-cause mortality - %||24.3||26.8||0.45||33.9||35.0||0.78||44.2||44.8||0.483|
|Stroke: all - %||6.0||3.2||0.08||7.7||4.9||0.17||8.2||9.3||0.763|
Note: These data refer to the intention-to-treat (ITT) population.
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 that enable 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 made by Mr. Wood and statements regarding future potential benefits and safety of the Edwards SAPIEN valve. 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 the outcomes to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected market developments or unanticipated outcomes of longer-term clinical trial and commercial experience. 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, 2012.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
i All percents for mortality and stroke data in this press release are Kaplan-Meier estimates.