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:6/27/2016)... ... June 27, 2016 , ... TherapySites, the ... affiliation with Tennessee Counseling Association. This new relationship allows TherapySites to ... Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited ...
(Date:6/26/2016)... Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in ... in honor of the city’s history as home to some of the world’s leading ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from ... at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center ... care topics including advance care planning, healthcare costs and patient and family engagement. ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Any dentist who has made an implant supported ... Many of them do not even offer this as a ... laboratory costs involved. And those who ARE able to offer ... high cost that the majority of today,s patients would not ... Zadeh , founder of Dental Evolutions Inc. and inventor of ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Key Pharma News Issue 52" report to their offering. ... need in influenza treatment creates a favourable commercial environment for ... and growing patient base that will serve to drive considerable ... flu vaccine would serve to cap sales considerably, but development ...
Breaking Medicine Technology: