50CC TOTAL ARTIFICIAL HEART

The SynCardia 50cc temporary Total Artificial Heart (TAH) is a smaller version of the SynCardia 70cc TAH, which has been approved as a bridge to transplant for more than a decade. The 50cc TAH is designed for use as a bridge to transplant in patients of smaller stature, allowing more women and adolescents to access this novel technology.

PATIENT DEMOGRAPHICS*

52% female | 48% male
22% pediatric (<18 years old)
Age range: 10 to 72 years old
Smallest BSA: 1.16m²

*As reported on SynCardia Implant Forms as of March 2020. Not all Implant Forms have complete information.

REGULATORY APPROVALS

Bridge to Transplant

FDA: March 2020
European CE mark: December 2014
Health Canada: January 2016

DEVICE SELECTION CRITERIA

Patients with adequate T10 measurement* or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments. The 50cc TAH is intended to support patients with a BSA ≤ 1.85m².

*posterior sternum to anterior spine measurement at T10

50CC TOTAL ARTIFICIAL HEART

PATIENT DEMOGRAPHICS*

REGULATORY APPROVALS

DEVICE SELECTION CRITERIA

LINKS