AB-180 circulatory support system: summary of development and phase I clinical trial.
The AB-180 Circulatory Support System (AB-180 CSS; Cardiac Assist Technologies, Pittsburgh, PA) is a left ventricular assist system for investigational use in patients with postcardiotomy cardiogenic shock who are refractory to standard treatment with an intra-aortic balloon pump, pharmacologic treatment, or both. The intent of the AB-180 CSS is to provide temporary (up to 14 days) mechanical circulatory support until the heart recovers adequate mechanical function. The system consists of a small implantable centrifugal pump and a controller. A unique infusion system produces a hydrodynamic bearing between rotational and stationary components of the AB-180 CSS pump. This infusion system also provides a source of heparin for localized anticoagulation. Extensive bench and animal work has illustrated anticoagulation requirements, established operating guidelines, and demonstrated safety and efficacy. An investigational device exemption has been granted for a Phase I, five patient feasibility study at Allegheny General Hospital in Pittsburgh, Pennsylvania. To date, the pump has been implanted in one patient. The results from this first case are presented here.
Griffin
W P
WP
Cardiac Assist Technologies, Pittsburgh, Pennsylvania 15238, USA.
Savage
E B
EB
Clark
R E
RE
Pacella
J J
JJ
Johnson
G A
GA
Magovern
J A
JA
Magovern
G J
GJ
D005240:Feasibility Studies; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design