Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences is still waiting on an approval decision from FDA on the first indication for its Sapien transcatheter aortic heart valve replacement, but CMS has decided not to wait.

You may also be interested in...



CMS Policy Sets Boundaries On Transcatheter Valve Procedure

New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.

Transcatheter Valve Coverage Proposal Reflects Stricter Medicare Environment

CMS’ proposed national coverage determination comes only three months after the approval and launch of Edwards Lifesciences’ Sapien, the first transcatheter aortic valve in the U.S. It restricts coverage to FDA-approved indications and includes a coverage-with-evidence-development provision.

The Latest On Transapical: Edwards Talks Up Sapien CAP Data

The non-randomized continued access program, which enrolled 822 transapical patients beyond the original randomized enrollment of 104 transapical patients, tells an improving story for transapical delivery for Sapien.

Related Content

Topics

UsernamePublicRestriction

Register

MT030579

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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