70CC TOTAL ARTIFICIAL HEART

The SynCardia 70cc temporary Total Artificial Heart (TAH) is the world’s first and only commercially approved total heart replacement. With more than 1,700 implants worldwide, the 70cc TAH accounts for more than 600 patient-years of support.

PATIENT DEMOGRAPHICS*

89% male | 11% female
Age range: 9 to 80 years old
Largest BSA: 2.96m²

*As reported on SynCardia Implant Forms as of 9 Oct 2017. Not all Implant Forms have complete information.

REGULATORY APPROVALS

Indication: for use as a bridge to donor heart transplant in cardiac transplant-eligible candidates at risk of imminent death from end-stage biventricular failure.

FDA: Oct. 15, 2004
European CE mark: Sept. 10, 1999
Health Canada: Oct. 27, 2005

CLINICAL TRIALS

Destination Therapy

In the U.S., the 70cc Total Artificial Heart is currently undergoing an FDA-approved Investigational Device Exemption (IDE) clinical trial for use as destination therapy in adult patients who are not eligible for heart transplantation.

DEVICE SELECTION CRITERIA

Patients with a T10 measurement* ≥ 10 cm or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments. The 70cc TAH is intended to support patients with a BSA ≥ 1.7m².

*posterior sternum to anterior spine measurement at T10

U.S. REIMBURSEMENT

When used as a bridge to transplant, the 70cc TAH is covered by Medicare (2008) and most large private payers and state Medicaid programs. The Centers for Medicare & Medicaid Services (CMS) has determined that the SynCardia 70cc Total Artificial Heart for Destination Therapy Study fulfills the requirement of the National Coverage Decision (NCD) for artificial hearts and related devices. This provides coverage with evidence development approved by CMS for reimbursement.