First artificial heart for critically ill approved
FDA gives OK to Abiomed to sell up to 4,000 artificial hearts for patients who couldn't get heart transplants; shares of company jump nearly 4%.
NEW YORK (CNNMoney.com) -- Federal regulators have approved the first totally implanted artificial heart for patients who aren't eligible for a heart transplant, the Food and Drug Administration announced Tuesday.
The AbioCore Implantable Replacement Heart is intended for patients who are close to death and have no other options.
The devices are approved for use in up to 4,000 patients a year, but it is expected that only 25 to 50 people will qualify, FDA spokeswoman Susan Bro told CNNMoney.com.
"This device represents a significant advance in artificial heart technology and holds promise for critically ill heart patients who are not candidates for heart transplants due to age or other medical conditions," Daniel Schultz of the FDA said in a statement.
The AbioCor system is a two-pound mechanical heart that pumps in place of the patient's diseased heart, which is removed during surgery.
The heart's internal battery allows the patient to be free from connections for up to an hour.
The device was approved under the FDA's Humanitarian Use Device provision, which seeks to encourage the development of medical devices to treat rare conditions.
Last year, Fortune Small Business looked at Abiomed's artificial heart. Read more on why it may be the future of cardiac care.