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

Edwards Wins Approval For Sapien Just In Time For TCT

This article was originally published in The Gray Sheet

You may also be interested in...



Edwards Reveals Sapien Launch Plans For Transapical Delivery Method

Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.

New Products In Brief

Recent PMA approvals include Edwards Lifesciences’ Sapien transcatheter aortic heart valve expanded indication, Bolton Medical’s Relay thoracic stent graft and Paradigm Spine’s Coflex interlaminar stabilization device.

Sapien Heart Valve Gets FDA Panel Nod For High-Risk Surgical Patients

Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.

Related Content

Topics

UsernamePublicRestriction

Register

MT030699

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