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

Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

HeartMate II update: Thoratec announces Dec. 4 that it has asked FDA to allow it to eliminate additional randomization in its destination therapy pivotal study of the HeartMate II continuous-flow ventricular assist device. The study protocol called for an interim analysis to test for the superiority of HeartMate II to HeartMate XVE when two-thirds of first 200 patients reached two-years of follow-up. The trial reached 200 patients in May 2007, and Thoratec says the interim analysis shows statistically superior outcomes for patients who received HeartMate II versus those who received the XVE. Since May 2007, the trial has enrolled another 407 patients under a continuous access protocol, including 166 in the randomized portion of the study. The company now hopes to file a PMA application for the destination therapy indication for HeartMate II in the first half of 2009

You may also be interested in...



Medtronic's DBS Epilepsy Therapy Reduces Seizures 68% At Three Years

Epilepsy patients treated with Medtronic's DBS deep brain stimulation therapy had a 68% median reduction in the frequency of seizures at three years compared to baseline, according to data released Dec. 6

Medtronic's DBS Epilepsy Therapy Reduces Seizures 68% At Three Years

Epilepsy patients treated with Medtronic's DBS deep brain stimulation therapy had a 68% median reduction in the frequency of seizures at three years compared to baseline, according to data released Dec. 6

Deep brain stimulation

Medtronic has filed a PMA for its deep brain stimulation therapy for patients with medically refractory epilepsy with partial-onset seizures. The application is supported by data from the randomized, double-blind Stimulation of the Anterior Nucleus of the Thalamus in Epilepy (SANTE) trial. Results presented in December at the American Epilepsy Society meeting showed that patients receiving DBS therapy in the left and right anterior nucleus of the thalamus, in conjunction with epilepsy medication, had significantly reduced seizure frequency compared to those receiving no stimulation (1"The Gray Sheet" Dec. 15, 2008). Medtronic has marketed the Activa DBS system for Parkinson's and essential tremor for more than 10 years

Related Content

UsernamePublicRestriction

Register

MT026904

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