FDA Gives Approval for Two New Designations for SynCardia’s Total Artificial Heart

by Kathy Jones on  March 21, 2013 at 8:15 PM Medical Gadgets
RSS Email Print This Page Comment
Font : A-A+

Arizona-based SynCardia Systems revealed that two of its Humanitarian Use Device (HUD) designations for the new 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant has been approved by the US Food and Drug Administration.
 FDA Gives Approval for Two New Designations for SynCardia’s Total Artificial Heart
FDA Gives Approval for Two New Designations for SynCardia’s Total Artificial Heart

The company added that the 50cc device is a smaller version of its 70cc SynCardia temporary Total Artificial Heart which had been approved by the FDA back in 2004.

The FDA approved HUD designation of the 50cc Total Artificial Heart for destination therapy on January 15 and is available for patients who are at a risk of imminent death from non-reversible biventricular heart failure while its use in treating biventricular heart failure in pediatric patients was approved on January 30.

"The 50cc Total Artificial Heart is designed to fit patients of smaller stature, including many women and adolescents who are too small to receive the 70cc Total Artificial Heart. We are pleased that the FDA recognized the needs of these underserved patient populations and was swift in approving the HUD designations. Together, the 70cc and 50cc Total Artificial Hearts will fit almost all adult men and women, and many adolescents, including patients with congenital conditions", SynCardia CEO and President, Michael Garippa said.

Source: Medindia

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
Notify me when reply is posted
I agree to the terms and conditions

More News on:

Heart Healthy Heart Statins Mitral Valve Prolapse Aortic Valve Stenosis 

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Stay Connected

  • Available on the Android Market
  • Available on the App Store

Facebook

News Category

News Archive