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:
- The court approved for SynCardia the retention of its professionals, debtor in possession financing and bid procedures;
- The second order provides SynCardia with access to money to continue to make purchases and operate in its normal course; and
- 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:
- 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;
- 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;
- Complete the FDA-approved destination therapy clinical study in the United States for patients who are not transplant eligible; and
- 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