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

Thoratec HeartMate A Good Choice For The Very Sick Despite Risks – Panel

This article was originally published in The Gray Sheet

Executive Summary

Thoratec's HeartMate VE left-ventricular assist system (LVAS) should be made available to end-stage heart failure patients ineligible for a transplant, even though 94% of patients treated with the LVAS in clinical trials experienced a serious adverse event, FDA's Circulatory System Devices Panel agreed

You may also be interested in...



Patient-Reported Outcomes In Device Trials: FDA Guidance Under Review

FDA is reviewing a draft guidance on use of patient-reported outcome data in device evaluations, according to Division of Cardiovascular Devices Medical Officer Neal Muni, MD

Patient-Reported Outcomes In Device Trials: FDA Guidance Under Review

FDA is reviewing a draft guidance on use of patient-reported outcome data in device evaluations, according to Division of Cardiovascular Devices Medical Officer Neal Muni, MD

Thoratec Hopes MCAC Will Follow Blues’ Lead To Cover Destination LVADs

Thoratec expects to meet with the Medicare Coverage Advisory Committee in early March to discuss expanding coverage of the HeartMate SNAP-VE left-ventricular assist device to include destination therapy for end-stage heart failure patients

Related Content

UsernamePublicRestriction

Register

LL016481

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