Who is the AbioCor Intended for?
The AbioCor is intended for use in end-stage heart
failure patients whose hearts have irreversible left
and right ventricular failure and for whom surgery
or medical therapy is inadequate.
In the initial clinical trial
the FDA and ABIOMED have determined patients must
meet the following criteria:
- Have end-stage heart failure.
- Have a life expectancy of less than 30 days.
- Not eligible for a natural heart transplant.
- Have no other viable treatment options.
How many patients could potentially benefit
from the AbioCor?
More than 700,000 Americans die each year from heart
failure, making it the number one cause of death in
the U.S., as well as worldwide. About half of these
are sudden cardiac deaths, which occur so quickly
that there is not enough time for intervention with
a cardiac assist or replacement device. For the remaining
half, heart transplantation is one of the few options
available today. Though hundreds of thousands are
in need, only about 2,000 people in the U.S. will
be able to receive donor hearts every year. This consistent
shortage in the supply of donor hearts in the U.S.
demonstrates the need for an alternative to heart
transplantation. The total potential maket for the
AbioCor is more than 100,000 people in the U.S. each
What type of patient could benefit from the
The AbioCor can be used with patients who suffer from
congestive heart failure or coronary heart disease.
Congestive heart failure, prevalent in older patients,
is a result of the progressive deterioration of the
heart over a number of years. Coronary artery disease
is prevalent at all ages and can lead to heart attacks
and chronic ischemic conditions. The AbioCor could
give patients with irreversibly failing hearts an
opportunity to both extend and improve the quality
of their lives and return to a productive lifestyle.
What is the AbioCor made of?
The AbioCor is primarily made of titanium and Angioflex™,
ABIOMED's proprietary polyether-based polyurethane
plastic. Angioflex has been developed and tested by
ABIOMED to be a dependable substance and safe for
contact with blood. The AbioCor is designed to have
relatively few moving parts. Moving parts such as
the valves and hydraulic membranes are manufactured
from Angioflex. Angioflex has proven flexible and
durable enough to withstand beating 100,000 times
a day (the approximate number of beats per day of
the natural heart). The AbioCor's smooth plastic construction
and unique design are specifically engineered to reduce
the likelihood of damage to blood cells and to prevent
How long do the batteries last?
The internal batteries of the AbioCor offer approximately
one-half hour of power, allowing patients to conduct
activities, such as taking a shower, without an external
power source or battery pack. External battery packs
can power the AbioCor for approximately 4 hours.