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

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 imm
'/>"/>

SOURCE SynCardia Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

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:1/14/2014)... 2014  Luminex Corporation (Nasdaq: LMNX ) today announced ... of 2013 on Monday, February 3, 2014. A press release ... of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) ... operating highlights and financial results for the fourth quarter and ...
(Date:1/14/2014)... 14, 2014 Dynamic Healthcare Services, Inc. ("DHS"), a portfolio ... acquired Progressive Home Medical Equipment, Inc. ("Progressive") of ... of the acquisition were not disclosed. Progressive ... a wide range of sleep, mobility, and respiratory products to ...
(Date:1/14/2014)... 2014   NuAire , a manufacturer of ergonomically designed laboratory ... Koki of Japan to sell and ... . NuAire will utilize its network of sales professionals throughout ... to offer assistance in application use, product benefits and ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
(Date:4/18/2014)... new medical-testing device is being prepped to enter ... improve diagnosis of certain diseases in remote areas, ... series of investigations aboard the International Space Station ... the space-tested concept of capillary flow to diagnose ... David Kelso, Ph.D., a researcher at Northwestern University ...
(Date:4/18/2014)... Hopkins University School of Medicine researchers have been awarded ... diabetes, Novo Nordisk announced this month. Of the 110 ... Obesity Biologics Science Forum Program, only four projects were ... researchers. They are Jonathan Powell, M.D., Ph.D.; G. William ... Jonathan Powell, a professor of oncology, will use his ...
(Date:4/18/2014)... made a brain-related discovery that could revolutionize doctors, ... discovery opens up the possibility that environmental and/or ... brain activity that the researchers have identified as ... of Neuroscience has just published a paper ... professor of psychology and his doctoral student John ...
(Date:4/18/2014)... A discovery by Northwestern Medicine scientists could lead to ... scarring in people with scleroderma. , Fibrosis, or ... tightening of the skin and lungs can lead to ... The concept for new therapeutic options centers on findings ... Medicine-Rheumatology, who identified the role that a specific protein ...
(Date:4/17/2014)... the first genetic variant specifically associated with the ... around 10-15 per cent of all breast cancer ... breast cancer sub-type, called invasive lobular carcinoma, gives ... this particular kind of breast cancer, which can ... today (Thursday) in the journal PloS Genetics ...
Breaking Medicine News(10 mins):Health News:Space-tested fluid flow concept advances infectious disease diagnoses 2Health News:Space-tested fluid flow concept advances infectious disease diagnoses 3Health News:Scientists discover brain's anti-distraction system 2Health News:New clues on tissue scarring in scleroderma 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 3
... Decreased muscle strength is associated with difficulty in ... kneeling (SCK) in older adults, according to an ... Physical Therapy (PTJ), the scientific journal ... researchers found that adults with SCK difficulty had ...
... They differ from each other in many ways, and they ... HIV to resist a host of weapons fired at ... emerging. One potential weapon is a small-molecule ... by attacking them through some feature common to an entire ...
... ... a Soho Seminar event that will help you transform the way employees engage inside and ... ... at the Soho Seminars event “Aligning the Corporate and Personal Brand,” hosted by Loyola ...
... effect on heart from androgen deprivation, official says ... with prostate cancer and the physicians who treat ... (ADT) commonly used against the malignancy might increase ... , "There is a substantial amount of data ...
... , PHILADELPHIA , ... GlaxoSmithKline plc will announce its full year financial results for the ... the announcement will be released to the London Stock Exchange at ... www.gsk.com . , Following the announcement, Andrew Witty , ...
... , , Rare, but serious, liver disorder ... 1 The U.S. Food and Drug Administration today announced ... has been reported in some HIV patients taking Videx/Videx EC ... is an antiretroviral medicine first approved by the FDA in ...
Cached Medicine News:Health News:Decreased muscle strength predicts functional impairments in older adults 2Health News:Decreased muscle strength predicts functional impairments in older adults 3Health News:Researchers find 'broad spectrum' antiviral that fights multitude of viruses 2Health News:Researchers find 'broad spectrum' antiviral that fights multitude of viruses 3Health News:7Summits to Present at Soho Seminars 'Alignment of Personal and Corporate Brands' 2Health News:Experts Issue Warning on Prostate Hormone Therapy 2Health News:Experts Issue Warning on Prostate Hormone Therapy 3Health News:GSK 2009 Financial Results Announcement and Teleconference Details 2Health News:FDA Announces Safety Risk Associated with HIV Drug 2
0.6mm Tip x10mm Shaft, Straight Shaft, 90 Degree Hook at Tip; overall length 120mm; in Titianium....
... SURPASS Perfusion Catheter is indicated ... stenotic portion of a coronary ... for the purpose of improving ... Catheters are also designed to ...
16mm from Mid-screw to Tips, blunt tips; overall length 110mm; Stainless Steel...
16mm from Mid-Screw to Blunt Tips, Gently Curved Blades; overall length 120mm; Stainless Steel...
Medicine Products: