AbioCor Implantable Heart Receives Additional Indication
Abiomed, Incorporated has received an additional approval from the FDA for the AbioCor Implantable Replacement Heart. The approval fell under the Agency’s Humanitarian Device Exemption supplement.
The AbioCor heart is the first completely self-contained artificial heart and does not include wires that pierce the patient’s skin. This reduces the opportunity for infections. The complete unit includes the internal elements: the thoracic element, a rechargeable battery, a power receiver coil, and miniatuarized electronic package. External components include the power and battery pack, handheld alarm monitor, power transmitter coil, and sophisticated computer console.
The AbioCor device is indicated for use in patients who have severely damaged hearts but are not eligible for a heart transplant and have no other potential treatment options. The device helps foster circulation throughout the body to simulate normal beating of the heart. Patients would otherwise die from heart failure.
With the device, patients are offered mobility and ongoing monitoring, which promotes remote diagnostic capabilities for clinicians. The device is also supposed to offer patients improved quality of life.
Under the terms of the new approval, AbioCor can be made available to a limited segment of the patient population in the United States. No more than 4,000 patients will receive the new device on an annual basis. Each unit costs approximately $250,000.
Initially, the devices will be rolled out to four different facilities in the United States. Those sites include Robert Wood Johnson University Hospital, the Texas Heart Institute at St. Luke’s Episcopal Hospital, St. Vincent’s Hospital, and the Johns Hopkins Hospital.
January 28, 2008 Related topics: Product Approval & Certification, Cardiology