The Hemopump in 1997: a clinical, political, and marketing evolution.

BACKGROUND

The Hemopump (Medtronic, Inc, Minneapolis, MN) was conceived in 1975 and designed in 1982 as a temporary, extracorporeal cardiac assist system. Although it has been used clinically in Europe, it is not currently available in the United States.

METHODS

In vitro and in vivo testing of the Hemopump began in 1983. Clinical investigations have included studies of patients in cardiogenic shock, Hemopump-supported coronary artery bypass operations in Sweden, and European studies of percutaneous transluminal coronary angioplasty (PTCA) with Hemopump support.

RESULTS

The Hemopump has demonstrated positive hemodynamic effects in patients. Laboratory and clinical studies have shown that the nonpulsatile axial flow generates flows of up to 4.5 L/min while maintaining adequate perfusion of other organs. In Europe, hemopumps have been used successfully to support coronary bypass and PTCA.

CONCLUSIONS

The Hemopump system is simple, inexpensive, and well tolerated by the blood elements. Moreover, its design allows flexibility in supporting patients during cardiopulmonary bypass (in lieu of conventional techniques) and high risk angioplasty, as well as in rescuing patients with low cardiac output.