Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

U.S. Approval Of Edwards Sapien Transcatheter Heart Valve Possible In 2009

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences is on track to begin a U.S. pivotal trial in early 2007 for its Sapien transcatheter aortic heart valve, making FDA approval possible by late 2009, according to the company

You may also be interested in...



Edwards Redesigns PARTNER Trial, Pushes Back Sapien Approval Timeline

Edwards Lifesciences has reached a verbal agreement with FDA on an amended design for the PARTNER trial of its Sapien transcatheter aortic valve, the company announced during its Dec. 7 2007 investor conference

Edwards Redesigns PARTNER Trial, Pushes Back Sapien Approval Timeline

Edwards Lifesciences has reached a verbal agreement with FDA on an amended design for the PARTNER trial of its Sapien transcatheter aortic valve, the company announced during its Dec. 7 2007 investor conference

Edwards Set To Launch “Two-Trials-In-One” For Sapien Percutaneous Valve

Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT024315

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel