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:1/20/2017)... , Jan 20, 2017 Research and ... Testing Market Trends, Opportunities, and Future" report to their offering. ... This research ... emerging trends, and technologies, and provides a snapshot of the key ... 2015 and forecasts are provided from 2016 to 2020. The market ...
(Date:1/20/2017)... Avillion LLP, a co-developer and financier of late-stage pharmaceutical product ... as Chief Medical Officer. Dr Weinberg will be based in ... ... than 17 years as a pharmaceutical and biotech executive with experience ... course of his career, he has interfaced with the US Food ...
(Date:1/19/2017)... The Global Therapy Partnering Terms and Agreements ... deals and agreements entered into by the world,s leading ... Top deals by value - Deals listed by company ... The report provides understanding and access to the partnering ... healthcare companies. The report provides an analysis of ...
Breaking Medicine Technology:
(Date:1/21/2017)... ... , ... Seamild, the largest manufacturer of oats in China, is now aiming ... As Oat is recognized globally as one of the healthiest cereals, XieQingkui, the founder ... is a move to sow the seed of good karma. Buddhism spirit featuring benevolence ...
(Date:1/21/2017)... ... January 21, 2017 , ... ... Dianne Travis-Teague, the electrifying line-up of events for its annual meeting “Coming Home ... and community. “Coming Home 2017” will be held on Friday January 27 ...
(Date:1/21/2017)... Santa Rosa, CA (PRWEB) , ... January 21, ... ... announce the opening of its new medical office in Petaluma, located at 167 ... full-service casting room, access to SRO sports medicine and rehabilitation services ...
(Date:1/21/2017)... ... January 21, 2017 , ... The ... Dr. Dan Holtzclaw in media for its creos™ line of bone regenerative products. ... Dr. Holtzclaw in which he utilizes creos™ allo.gain™ bone graft for a variety ...
(Date:1/20/2017)... ... , ... A new partnership between Goodwill® and Roadie, Inc. aims to make ... clothes to couches to dressers and bicycles. Roadie — the national on-the-way delivery network ... donation center through February 28th. , “January is an exciting time when resolutions ...
Breaking Medicine News(10 mins):