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

FDA Expands Inclusion Criteria For WorldHeart LVAS Destination Therapy Trial

This article was originally published in The Gray Sheet

Executive Summary

FDA has given conditional approval for WorldHeart to modify its pivotal trial of the Novacor implantable heart-assist pump. The changes are expected to accelerate the study, which has moved slowly since its start in 2004

You may also be interested in...



Thoratec completes HeartMate PMA

Firm submits the last module of the PMA for its HeartMate II next-generation, rotary-flow left ventricular assist system seeking approval for patients waiting for heart transplants on Dec. 22. The filing is based on data from 133 bridge-to-transplantation patients who used the device from one to 568 days. A trial is ongoing for the device as a destination therapy (1"The Gray Sheet" May 1, 2006, p. 12)...

Thoratec completes HeartMate PMA

Firm submits the last module of the PMA for its HeartMate II next-generation, rotary-flow left ventricular assist system seeking approval for patients waiting for heart transplants on Dec. 22. The filing is based on data from 133 bridge-to-transplantation patients who used the device from one to 568 days. A trial is ongoing for the device as a destination therapy (1"The Gray Sheet" May 1, 2006, p. 12)...

HeartMate II trial fully enrolled

Thoratec completes enrollment for the bridge-to-transplantation arm of its HeartMate II left ventricular assist system, implanting 133 patients. The May 31 announcement notes recent FDA approval to enroll up to 90 additional patients, which Thoratec says will not impact the timing of a planned PMA submission for the device. Enrollment is ongoing for the 200-patient destination therapy arm of the trial comparing HeartMate II with HeartMate XVE in end-stage heart failure patients who don't qualify for a transplant (1"The Gray Sheet" May 1, 2006, p. 12)...

Latest Headlines
See All
UsernamePublicRestriction

Register

MT023494

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