Navigation Links
SynCardia's 50cc Total Artificial Heart Receives Two HUD Designations from the FDA for Destination Therapy and Pediatric Bridge to Transplant
Date:2/28/2013

TUCSON, Ariz., Feb. 28, 2013 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the U.S. Food and Drug Administration (FDA) has approved two Humanitarian Use Device (HUD) designations for the new 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant. The 50cc device is a smaller version of the 70cc SynCardia temporary Total Artificial Heart, which received FDA approval as a bridge to transplant in 2004.

(Photo: http://photos.prnewswire.com/prnh/20130228/LA68124)

"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," said Michael Garippa , SynCardia Chairman/CEO/President. "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."

  • HUD for Destination Therapy:
    On Jan. 15, the FDA granted a HUD designation for the 50cc Total Artificial Heart to be used for destination therapy. To be eligible, patients must be at risk of imminent death from non-reversible biventricular heart failure, not eligible for cardiac transplant and have a Body Surface Area (BSA) between 1.2 and 1.79m2.
  • HUD for Pediatric Bridge to Transplant:
    On Jan. 30, the FDA granted a HUD designation for the 50cc Total Artificial Heart to be used for the treatment of biventricular heart failure in pediatric patients with a BSA that can sufficiently accommodate the device (i.e. between 1.2 and 1.7m2).

A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for each indication of the 50cc Total Artificial Heart.

Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapy, and an additional 4,000 pediatric patients to receive the device as a bridge to transplant.

About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,100 implants of the Total Artificial Heart, accounting for more than 300 patient years of life.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Forbes Ranks SynCardia #69 Among "America's Most Promising Companies" 
In its February 2013 issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. To see the full list of SynCardia Awards & Recognition go to: http://www.syncardia.com/SynCardia/syncardia-awards-and-recognition.html.

Like SynCardia on Facebook - http://www.facebook.com/pages/SynCardia-Systems-Inc/191245900926019  
Follow SynCardia on Twitter - http://twitter.com/SynCardia


'/>"/>
SOURCE SynCardia Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Retired Pro Hockey Player 1st to Receive Total Artificial Heart in Upstate New York
2. MDHI in Agreement with Debt Holders - Portion of Convertible Debt and Additional 14M Warrants Cancelled -- Total of 101M Warrants Cancelled this Year
3. 3 Pediatric Centers that Offer SynCardia Total Artificial Heart Named in Top 10 for "Best Childrens Hospitals"
4. Total Therapeutic Management, Inc. invites directors of quality improvement to learn secrets of provider engagement strategies
5. 1st SynCardia Total Artificial Heart Implant Performed in New England
6. 50% of U.S. News & World Reports "Best Hospitals" for Cardiology & Heart Surgery Making the SynCardia Total Artificial Heart Part of Their Toolbox
7. Introducing DenMats Totally New Web Site @ DenMat.com Featuring a New On-Line Store, New Page Design & Special On-Line Savings
8. Met-Pro Corporations Strobic Air Business Unit Receives New Equipment Orders Totaling Approximately $1.5 Million
9. Solos Endoscopy Posts Total Assets of $2,426,883 for Period Ended June 30, 2012
10. SynCardia Total Artificial Heart Patient Featured in U.S. News & World Reports "Best Hospitals" Issue
11. 1st SynCardia Total Artificial Heart Patient Discharged from Ankara University in Turkey
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/12/2017)... PARIS and NEW YORK , Sept. 12, ... ethical performance ratings for global supply chains, has published the first annual ... the CSR performance of more than 20,400 companies evaluated by EcoVadis, based ... years 2015 and 2016. ... EcoVadis Global CSR Risk & Performance Index ...
(Date:9/12/2017)... FRANCISCO , Sept. 12, 2017  ValGenesis ... Management Solutions (VLMS), is pleased to announce the ... a member of its Board of Directors and ... ValGenesis VLMS enables life science companies to manage ... the use of paper in this process. Furthermore, ...
(Date:9/9/2017)... , Sept. 8, 2017 Dealmed Medical ... independent supplier of medical equipment, supplies, drugs, vaccines, and ... has entered into an agreement to acquire Vantage Medical ... based in Holtsville, New York . ... in supplying new and emerging medical practices, will operate ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... ... ... HMP , a leader in healthcare events and education, today announced that ... ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie & Ozzie Awards luncheon ... editorial and design excellence across a range of sectors. This year’s program included the ...
Breaking Medicine News(10 mins):