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

FDA Panel Urges Safety Studies Of Cooling-Catheters For Cardiac Arrest Group

This article was originally published in The Gray Sheet

Executive Summary

Clinical trials of endovascular cooling catheters should focus primarily on safety, since the devices are at least as effective as surface cooling methods to achieve hypothermia-induced resuscitation, FDA panelists agreed Sept. 21

You may also be interested in...



Alsius Tries To Warm FDA Panel To CoolGard 510(k), Gets Chilly Response

FDA should see convincing data from a three-arm, randomized controlled trial before granting 510(k) clearance to Alsius' CoolGard 3000 heat-exchange catheter system, Circulatory System Devices Panel members suggested March 17

Alsius Tries To Warm FDA Panel To CoolGard 510(k), Gets Chilly Response

FDA should see convincing data from a three-arm, randomized controlled trial before granting 510(k) clearance to Alsius' CoolGard 3000 heat-exchange catheter system, Circulatory System Devices Panel members suggested March 17

FDA panel to rate cooling catheter

Circulatory System Devices Panel convenes March 17 in Gaithersburg, Md. to review a 510(k) submission for a device applying mild hypothermia to treat patients rendered unconscious by cardiac arrest. Alsius' CoolGard system, which uses a proprietary catheter to fill two MicroTherm cooling balloons in the superior vena cava, currently lacks the indication under review. [Editor's note: To order a webcast or DVD of the panel meeting, visit "The Gray Sheet" affiliate 1www.FDAAdvisoryCommittee.com.] Radiant Medical markets Reprieve, a second-gen version of the SetPoint endovascular temperature management system, cleared in 2002 for "cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care." Panelists agreed last September that safety studies are needed to assess hypothermia as therapy for comatose patients after cardiac arrest (2"The Gray Sheet" Sept. 27, 2004, p. 5)...

Related Content

UsernamePublicRestriction

Register

MT020944

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