In Vivo is part of the Business Intelligence Division 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

Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve

This article was originally published in The Gray Sheet

Executive Summary

It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.

Advertisement

Related Content

Medtronic’s CoreValve Makes Strides In Japan And U.S.
TAVR Registry Data Triggers Expansion Of FDA-Approved Indication
Edwards Finds Transcatheter Valve Adoption In U.S. Slower Than Expected
First PARTNER II Results Show Progress With Edwards’ TAVR Technology
Edwards Reveals Sapien Launch Plans For Transapical Delivery Method
CMS Policy Sets Boundaries On Transcatheter Valve Procedure
Edwards Can Proceed With Next-Gen Transcatheter Valve Study

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

MT032709

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