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