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

WorldHeart gets US OK to accelerate heart pump destination therapy trial:

This article was originally published in Clinica

Executive Summary

WorldHeart may have moved closer to taking its pulsatile heart pump to the US destination therapy market, after the FDA said it could make timesaving modifications to a clinical trial of the device. Trial design changes expected to accelerate the study's completion include a sample size reduction from 390 to 208 patients and broader patient inclusion criteria that should speed up the patient enrolment rate. The trial, called RELIANT Destination Therapy, is assessing the firm's Novacor left ventricular assist system and has already enrolled nearly 20% of the newly required number. The FDA has already approved the device as a bridge to transplantation.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT051556

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