Technology | August 11, 2014

FDA Approves SynCardia Total Artificial Heart With SynHall Valves

SynCardia Systems Inc. now controls last key component in heart manufacturing

SynCardia Total Artificial Heart SynHall Valves FDA approval

SynCardia Systems Inc. received FDA approval to manufacture the SynCardia Total Artificial Heart with SynHall valves. The OK gives the company control over the two critical components for heart manufacturing: The valves and the unique formula for segmented polyurethane solution (SPUS), which is manufactured only by SynCardia.

August 11, 2014 — SynCardia Systems Inc. received approval in July from the U.S. 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 in April 2014. Health Canada approval was received for the same purpose in July.

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 more than 5,000 valves and more than 30 years of use.

SynCardia 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 more information: www.syncardia.com

Related Content

CorInnova Awarded 2017 InnoSTARS Prize for EpicHeart Soft Robotic Heart Assist Device
News | Artificial Heart | December 11, 2017
CorInnova Inc. recently announced it was awarded second prize in the “2017 InnoSTARS” life science competition for its...
CorInnova Awarded Seminal Patent for Minimally Invasively-Delivered Soft Robotic Heart Device
News | Artificial Heart | October 27, 2017
CorInnova Inc. announced it has received notice of allowance of a seminal patent to protect its intellectual property...
SynCardia, Chapter 11 reorganization, sale, Total Artificial Heart
News | Artificial Heart | September 13, 2016
August 29, 2016 — SynCardia Systems, manufacturer of the...
Carmat, bioprosthetic artificial heart, PIVOTAL study, first implantation, heart failure
News | Artificial Heart | September 09, 2016
Carmat announced that the first implantation of its bioprosthetic artificial heart within the framework of the PIVOTAL...
SynCardia Total Artificial Heart, TAH-t, documentary, Retro Reports, The New York Times
News | Artificial Heart | March 24, 2016
March 24, 2016 — A new documentary produced by Retro Report for The New York Times looks at the history and
Bryan Tyo, Baylor University Medical Center, bridge to transplant, Total Artificial Heart
News | Artificial Heart | March 18, 2016
A surgical team at Baylor University Medical Center at Dallas successfully performed a heart transplant on a patient...
Overlay Init