ABIOMED, Inc. | MedPath

FDA Approves First Fully Implantable Artificial Heart for End-Stage Patients

19 years ago

• The FDA has approved the AbioCor Implantable Replacement Heart, the first completely implantable artificial heart, for patients with severe heart failure who are ineligible for a heart transplant. • The device is intended for individuals with acute heart failure who are not candidates for heart transplantation and have a life expectancy of less than a month. • Clinical trials demonstrated that the AbioCor extended survival by an average of 4.5 months, providing patients with valuable time with family and friends. • Abiomed Inc. developed the artificial heart, which replaces the patient's own heart and includes a power transfer coil, internal battery, and controller.