News | Artificial Heart | September 13, 2016

SynCardia Artificial Heart to Emerge from Chapter 11 Reorganization With New Owner

Court-approved plan will see business sold to Sindex by Sept. 16 of this year

SynCardia, Chapter 11 reorganization, sale, Total Artificial Heart

August 29, 2016 — SynCardia Systems, manufacturer of the Total Artificial Heart (TAH), announced that the judge overseeing its Chapter 11 reorganization has approved the conditions for the bankruptcy process.

The judge approved the following:

  1. The court approved for SynCardia the retention of its professionals, debtor in possession financing and bid procedures;
  2. The second order provides SynCardia with access to money to continue to make purchases and operate in its normal course; and
  3. The last order entered provides for the sale of the business to Sindex. The court, after hearing all the arguments, granted a workable and reasonable time table for the business to be marketed and sold in the near-term, with a sale date of Sept. 16, 2016.

SynCardia said its plans for the future remain unchanged. They include the following initiatives:

  1. Complete the next generation of Freedom portable driver, which will be smaller, lighter and virtually silent. The Freedom driver powers SynCardia Total Artificial Hearts and provides patients with nearly unlimited mobility;
  2. Complete the U.S. Food and Drug Administration (FDA)-approved 50cc TAH-t clinical study in the United States. The 50cc is a smaller version of SynCardia 70cc TAH-t and fits women, adolescents and men of smaller stature. The 50cc TAH-t has already been approved for use in Europe;
  3. Complete the FDA-approved destination therapy clinical study in the United States for patients who are not transplant eligible; and
  4. Expand the availability of the SynCardia Total Artificial Heart to underserved populations and geographies.

The International Society for Heart and Lung Transplantation (ISHLT) recently issued the first annual report of its Mechanically Assisted Circulatory Support (IMACS) registry. The global registry monitors the outcomes of patients receiving durable mechanical circulatory support (MCS) devices in all countries and hospitals wishing to participate.

According to the latest statistics in the IMACS report, 73.5 percent of patients implanted with the SynCardia Artificial Heart were either alive on the device (26.3 percent) or were transplanted (47.2 percent) at six months. This is the highest bridge-to-transplant rate for any durable device.

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...
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