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Frequently Asked Questions
What is the AbioCor device?
The AbioCor, developed by Abiomed, Inc., is intended as a permanent heart replacement for end-stage heart failure patients who are not candidates for transplant and cannot be helped by any other available treatment.
Made primarily of titanium and blood-safe plastic, the AbioCor is designed so that a patient can remain mobile and continue a productive lifestyle. Equipped with an internal motor, the AbioCor is able to move blood through the lungs and to the rest of the body, simulating the rhythm of a heartbeat. The AbioCor consists of an internal thoracic unit, an internal rechargeable battery, an internal miniaturized electronics package and an external battery pack.
It is designed not only to extend the lives of patients who would otherwise die of heart failure, but also to offer a satisfactory quality of life.
Why have Robert Wood Johnson University Hospital and Robert Wood Johnson Medical School decided to offer the AbioCor fully implantable artificial heart as an option to patients?
Over the past decade, Robert Wood Johnson University Hospital has established a reputation as a leader in the field of cardiac care, as well as cardiac and kidney transplantation. Organ transplantation is often referred to as the “ultimate second chance” or the “ultimate gift of life.” With that thought in mind, we believe that the AbioCor device is a natural progression of our current technology and capabilities in these fields and we are committed to making the full range of all possible treatments and therapies available to patients who may have limited or no other treatment options available to them.
How are patients identified to receive the AbioCor device?
Patients selected to receive the AbioCor must meet the criteria that has been established as part of the FDA approval. The AbioCor is indicated for use in severe, biventricular, end-stage heart disease patients who are not cardiac transplant candidates and who:
- Are less than 75 years old;
- Require multiple inotropic support;
- Are not treatable by left ventricular assist device (LVAD) destination therapy; and
- Are not weanable from biventricular support if on such support.
The screening process takes place in three steps:
- Determination that the patient is not eligible for a transplant;
- The patient will undergo an AbioFit assignment to see if the device will fit in the patient’s chest without causing any obstructions; and
- Determination of biventricular failure.
Once it is established that the patient has met the FDA criteria, he/she will be asked to sign the Informed Consent Form in order to proceed with the implant.
What are some benefits of the AbioCor device?
Some of the potential benefits include:
- Increase in life expectancy – Patients who receive the AbioCor have end-stage heart failure and are at imminent risk of death. The AbioCor may prolong life; however, it is difficult to know for how long compared to what would have happened without the device.
- Lower risk of infection – The AbioCor system is totally implantable. As a result, there may be a lower risk of infection compared to other devices that penetrate the surface of the skin.
- Improved quality of life – A patient’s quality of life during the time he or she is supported by the AbioCor system may be better than the quality of life would have been if the patient were receiving conventional medical therapy.
- Extended time with family and friends – By extending life, the AbioCor may provide patients with valuable time with family and friends.
- Patient autonomy – Patients may benefit from knowing that they have some decision-making ability or some control over their final treatment choices. They may find some satisfaction in having their decision honored and by knowing that all treatment options have been explored.
What type of training has the surgical team received for this procedure?
The entire surgical and post-surgical team has gone through a three-phase training program and has been certified to perform the AbioCor procedure. Sessions have included lecture presentations and hands-on, clinical training.
What does FDA approval of the device mean?
The Food and Drug Administration (FDA) approved the AbioCor for use under a Humanitarian Device Exemption (HDE). This means that the FDA has found the device to be safe and provide probable benefit to patients with end-stage heart failure on both sides of the heart who have no other treatment options.
The FDA requires a Post-Approval Study to monitor the use of the AbioCor while it is being marketed in the United States. This further testing helps to ensure that results in actual clinical use are at least similar to those observed in the clinical trial. The AbioCor Post-Approval Study will evaluate at least 25 patients in multiple U.S. heart centers.
Has this procedure been performed, or will it be performed, outside the U.S.?
The AbioCor is not approved in any other country at this time.