Navigation Links
Edwards Lifesciences Receives Additional Questions From the FDA About the LifeStent Product Line
Date:5/30/2008

IRVINE, Calif., May 30 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), a world leader in products and technologies to treat advanced cardiovascular disease, said today that it has received additional questions from the U.S. Food and Drug Administration (FDA) regarding the company's submission for premarket approval of LifeStent products for a superficial femoral artery (SFA) indication. These questions pertain to preclinical bench testing and the clarification of open items already under review by the FDA. Edwards expects to respond promptly to the FDA and continues to anticipate receiving an SFA indication by the end of the year. Earlier this year, Edwards completed the sale of the LifeStent product line to C.R. Bard, Inc.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.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, the company's ability to promptly respond to the FDA's questions and receive an SFA indication by the end of the year. 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.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements 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, 2007.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.


'/>"/>
SOURCE Edwards Lifesciences Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Aflac to be Primary Sponsor of Carl Edwards and the No. 99 Ford Fusion
2. Edwards Lifesciences Announces Retirement of Director Vernon Loucks
3. Edwards Lifesciences to Host Earnings Conference Call on April 22, 2008
4. Optimal Readings Appoints Operations Veteran Rita Edwards as SVP Clinical Operations
5. Edwards Lifesciences Chairman and CEO Adopts New 10b5-1 Stock Trading Plan to Replace Recently Expired Plan
6. Edwards Lifesciences to Present at the Citi 5th Annual Small and Mid-Cap Conference
7. Edwards Lifesciences to Present at the Cowen and Company Annual Healthcare Conference
8. Edwards Lifesciences Initiates Patent Infringement Litigation Against CoreValve in the U.S.
9. Edwards Lifesciences Reports Strong Fourth Quarter Sales
10. Edwards Lifesciences Completes Sale of LifeStent Product Line to Bard
11. Edwards Lifesciences to Present at the Southern California Investor Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... ... January 16, 2017 , ... ... partnership with an innovator in the wheelchair accessibility industry, BraunAbility . Incentive ... salespeople to sell wheelchair accessible vehicles. With this new incentive plan, BraunAbility plans ...
(Date:1/16/2017)... ... January 16, 2017 , ... In 1985, the International ... training standards to an international multidisciplinary group of healthcare treatment providers and helping ... to further its mission at the grassroots level, iaedp launched MemberSHARE, an online ...
(Date:1/16/2017)... ... January 16, 2017 , ... NexTec Group has been selected as a ... honored for their accomplishments in the field of midmarket financial software. , Members of ... and innovation. Selection is not based on revenue and those firms chosen represent a ...
(Date:1/15/2017)... (PRWEB) , ... January 15, 2017 , ... ... that Albertsons Companies has achieved accreditation for its specialty care services. Albertsons ... its own in-house specialty care service for pharmacy patients. , Accreditation by ACHC ...
(Date:1/15/2017)... ... January 15, 2017 , ... The Gravity Vault Indoor Rock Climbing ... As construction wraps up on the 14,000+ square foot climbing gym, the owners anticipate ... including three in New Jersey and two in New York. With this being its ...
Breaking Medicine News(10 mins):
(Date:1/16/2017)...  Northern Colorado,s newest tattoo removal clinic, The ... Loveland featuring the Astanza Duality ... of unwanted tattoos and delivers complete tattoo removal, selective ... "Tattoos are beautiful forms of self-expression, however, not all ... said Johnny Trzasko , owner. "The Ink Shrinks ...
(Date:1/16/2017)... and PUNE, India , January 16, 2017 /PRNewswire/ ... titled, "Antioxidants Market by Type - Global Opportunity Analysis and Industry Forecast, 2014 ... expected to reach $4,531 million by 2022, registering a CAGR of 6.42% during ... more than one-third share of the global volume in 2015. ... ...
(Date:1/16/2017)... January 16, 2017 Bill is an internationally ... general management and leadership positions with global medical device companies, including ... track record of launching new products and building successful businesses in ... Africa and North America ... Educated at ...
Breaking Medicine Technology: