Table 1.
Summary of commissioned rotary mechanical circulatory support systems.
Device | Manufacturer | Flow | Side | Location | Suspension and bearings | Size | Output | Approvals |
---|---|---|---|---|---|---|---|---|
HeartAssist 5 | ReliantHeart | Axial | LV | Intracorporeal | Hydrodynamic (purged) | 30(D) × 71(L) | 5–10 lpm | FDA (BTT adult) trials, FDA (BTT pediatric), EU (BTT, DT) |
HeartMate II | Thoratec | Axial | LV | Intracorporeal | Mechanical (blood immersed) | 40(D) × 60(L): 63 mL | 3–10 lpm | FDA (BTT, DT), EU (BTT, DT) |
INCOR | Berlin Heart | Axial | LV | Intracorporeal | Electromagnetic | 30(D) × 114(L) | 5 lpm | FDA (BTT) trials, EU (BTT, DT) |
Impella | Abiomed | Axial | LV, RV, BV | Transvalvular | Magnetic and hydrodynamic | 12 Fr to 21 Fr | 2.5–5 lpm | FDA (6 h), EU |
HeartWare HVAD | HeartWare | Centrifugal | LV, RV, BV | Intracorporeal | Electromagnetic and hydrodynamic | 50 mL | 10 lpm | FDA (BTT), FDA (DT) trials, EU (BTT, DT) |
HeartMate III | Thoratec | Centrifugal | LV | Intracorporeal | Electromagnetic | 69(D) × 30(H): 50 mL | 13 lpm | FDA trials, EU |
CentriMag | Thoratec | Centrifugal | LV, RV, BV | Extracorporeal | Magnetic | 31 mL | 9.9 lpm | FDA (6 days LVAD and 30 days RVAD), EU (30 days) |
PediMag | Thoratec | Centrifugal | LV, RV, BV | Extracorporeal | Magnetic | 14 mL | 1.5 lpm | FDA (6 days), EU (30 days) |
EvaHeart | EvaHeart | Centrifugal | LV | Intracorporeal | Hydrodynamic (purged) | 55(D) × 64(H): 132 mL | 12 lpm | FDA (BTT) trials |
BPX-80 | Medtronic | Centrifugal | LV | Extracorporeal | Mechanical | 79(D) × 66(H): 86 mL | 10 lpm | FDA (6 h), EU |
BP-50 | Medtronic | Centrifugal | LV | Extracorporeal | Mechanical | 48 mL | 1.5 l pm | FDA (6 h), EU |
Synergy | HeartWare | Mixed | LV, RV, BV | Intracorporeal | Magnetic and hydrodynamic | 12(D) × 49(L): 1.5 mL | 0.3–6 lpm | FDA (BTT, BTR) trials, EU (BTT, BTR) |
BTD: bridge to decision; BTR: bridge to recovery; BTT: bridge to transplant; DT: destination therapy; VAD: ventricular assistive device; TAH: total artificial heart; FDA: Food and Drug Administration; BV: biventricular; LV: left ventricle; RV: right ventricle.