Navigation Links
FDA Approves the SynCardia Total Artificial Heart With SynHall Valves
Date:8/5/2014

TUCSON, Ariz., Aug. 5, 2014 /PRNewswire/ -- SynCardia Systems, Inc. received approval July 2, 2014 from the United States Federal Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall™ valves, giving the company control over the last key component to manufacture the Total Artificial Heart.

FDA approval follows SynCardia's receipt of the CE Mark for European use of the SynHall valves only in the SynCardia Total Artificial Heart on April 17, 2014. Health Canada approval was received for the same purpose on July 28, 2014.

The SynHall valves only for use in the SynCardia Heart are of the same design, materials and nearly identical manufacturing processes as the tilting-disk valves that have always been used in the Total Artificial Heart.

Made of titanium and pyrolytic carbon, these robust valves have never failed in more than 1,300 implants of the SynCardia Total Artificial Heart, accounting for well over 5,000 valves and over 30 years of use.

"We're delighted that the SynHall valves passed the FDA's rigorous approval process," says Michael P. Garippa, SynCardia CEO and President.

The company also controls manufacture of segmented polyurethane solution (SPUS), which is used in the SynCardia Total Artificial Heart's housings, diaphragms and connectors. SynCardia is the only source of SPUS in the world.

For additional information, please visit: http://www.syncardia.com/

About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and 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 biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 175 patients, accounting for over 100 years of support.

Photo - http://photos.prnewswire.com/prnh/20140804/133128


'/>"/>
SOURCE SynCardia Systems, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related biology technology :

1. USDA/GIPSA Approves Charm Sciences’ ROSA® FAST Aflatoxin Quantitative Test
2. Kansas Bioscience Authority Approves $700,000 in Investments
3. Cell Therapeutics, Inc.s (CTI) Board of Directors Approves Amendment of Shareholder Rights Plan
4. ABET Approves Criteria for Optics and Photonics Engineering Undergraduate Degrees in United States
5. 2012 American Business Awards?Honors SynCardia with Two Gold Stevie® Awards
6. Top 10 “Best Children’s Hospitals” Include 3 Pediatric Centers Offering SynCardia Total Artificial Heart
7. University of Kentucky Medical Center Transplants States 1st SynCardia Total Artificial Heart Patient
8. Nebraska Medical Center Implants States First SynCardia Total Artificial Heart
9. SynCardia Total Artificial Heart Featured in $3 Million Exhibition at Glasgow Science Centre
10. SynCardia Total Artificial Heart Bridges Former Semi-Pro Arena Football Player to Heart Transplant
11. 7 SynCardia Certified Centers Honored Among “Best Children’s Hospitals” for Cardiology and Heart Surgery by U.S. News & World Report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... 2016  Liquid Biotech USA ... a Sponsored Research Agreement with The University of ... from cancer patients.  The funding will be used ... with clinical outcomes in cancer patients undergoing a ... be employed to support the design of a ...
(Date:6/24/2016)... ... ... While the majority of commercial spectrophotometers and fluorometers use the z-dimension of 8.5 ... end machines that use the more unconventional z-dimension of 20mm. Z-dimension or ... the cuvette holder. , FireflySci has developed several Agilent flow cell product lines ...
(Date:6/23/2016)... June 23, 2016   Boston Biomedical , ... compounds designed to target cancer stemness pathways, announced ... granted Orphan Drug Designation from the U.S. Food ... gastric cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin ... to inhibit cancer stemness pathways by targeting STAT3, ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
Breaking Biology Technology:
(Date:6/1/2016)... 2016 Favorable Government Initiatives Coupled ... Criminal Identification to Boost Global Biometrics System Market Through ... Research report, " Global Biometrics Market By Type, ... Opportunities, 2011 - 2021", the global biometrics market is ... account of growing security concerns across various end use ...
(Date:5/9/2016)... , UAE, May 9, 2016 ... it comes to expanding freedom for high net worth ... Even in today,s globally connected world, there is still ... system could ever duplicate sealing your deal with a ... second passports by taking advantage of citizenship via investment ...
(Date:4/26/2016)... 27, 2016 Research and ... Biometrics Market 2016-2020"  report to their offering.  , ... The analysts forecast the global multimodal biometrics ... during the period 2016-2020.  Multimodal biometrics ... such as the healthcare, BFSI, transportation, automotive, and ...
Breaking Biology News(10 mins):