Risks

As with open heart surgery of any kind, there are risks, including death. Each patient should discuss possible risks and benefits with his/her own doctor before deciding what treatment is best.

Although risk is inevitable in the application of any medical technology, the Jarvik 2000 FlowMaker® has been developed and tested to minimize complications. Perhaps the Jarvik 2000’s most important attributes in this regard are the simplicity and economy of its design.

Infection and Clots

With no inflow or outflow valves and no air vent tube to the outside of the body, the Jarvik 2000 eliminates the risk of problems associated with these components. The very small size of the Jarvik 2000 allows it to be implanted inside the natural heart’s left ventricle. Its positioning inside the heart eliminates the risk of infection in a “tissue capsule” around the outside of the device because no such capsule forms. However there is risk of infection with all ventricular assist devices.

Stroke from blood clots are a risk with any ventricular assist device. Better surgical technique and better anticoagulation management can further reduce the rate of blood clots associated with any ventricular assist device.

Device Reliability

As a device that must operate safely inside the human body for long periods of time, the Jarvik 2000 has shown itself to be highly reliable, with no bearing failures of the implanted blood pump in more than 900 implants to date. The titanium, blood-contacting surfaces are highly polished, biocompatible, and remain corrosion free in the harsh environment that blood creates. The small, spinning impeller responsible for generating the blood flow through the pump causes no clinically significant damage to blood cells.