GIVE PATIENTS THE GIFT OF TIME
The SynCardia temporary Total Artificial Heart (TAH-t) is a treatment option for cardiac transplant-eligible patients at risk of imminent death from biventricular failure.
WHAT IS THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART?
The TAH-t is a pneumatically driven pulsatile system used for the temporary replacement of the native ventricles and four valves in cases of end-stage biventricular heart failure.
The housings, diaphragms and connectors in the TAH-t are made from a highly specialized segmented polyurethane solution. The compound offers a high degree of biocompatibility, fatigue resistance and strength.
The TAH-t consists of two independent artificial ventricles and is available in two sizes — 70cc and 50cc. The 70cc ventricle has a maximum stroke volume of 70mL and is capable of generating a cardiac output of up to 9.5 L/min. The 50cc ventricle has a maximum stroke volume of 50mL and is capable of generating a flow rate of up to 7.5 L/min.
Each ventricle is divided by a multi-layer flexible polyurethane diaphragm that separates the blood chamber from the air chamber.
The polyurethane ventricles are connected by Velcro, which allows for flexible positioning inside the chest cavity.
The direction of blood flow is controlled by four SynHall (formerly Medtronic MedHall) tilting disc valves that are mounted in the inflow and outflow ports of each artificial ventricle. These high-performing valves have proven to be extremely durable and dependable for long-term support.
The cannula of each artificial ventricle acts as a conduit for air from the driver to the ventricles. Each cannula is partially covered with velour fabric to promote tissue ingrowth, is tunneled through the chest wall and attaches to drivelines that connect to the external pneumatic driver.
Both the Companion 2 Hospital Driver and the Freedom® Portable Driver (approved for use at home) run on lithium ion batteries, as well as A/C power.
TWO SIZES TO FIT MOST PATIENTS
70CC TAH-t
Device Selection Criteria
Patients with a T10 measurement* ≥ 10 cm. Patients supported by the 70cc TAH-t typically have a body surface area (BSA) ≥ 1.7m2.
Approvals
- Bridge to Transplant
- Approved in the U.S. (2004), Canada (2005)
*posterior sternum to anterior spine measurement at T10
50CC TAH-t
Device Selection Criteria
Physicians can now offer the TAH-t to patients with smaller thoracic dimensions including small statured adults, and some pediatric patients. 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-t is intended to support patients with a BSA ≤ 1.85m2.
Approvals
- Bridge to Transplant
- Approved in Canada (2016), and the U.S. (2020)
*posterior sternum to anterior spine measurement at T10