ABIOMED, Inc. today announced the 14th implantation of the AbioCor® Implantable Replacement Heart. The implant was performed on May 24 in Louisville, KY by a Jewish Hospital/University of Louisville medical team led by surgeons Laman Gray, M.D. and Rob Dowling, M.D. The procedure went well and without complication. The patient is recovering, and is in critical but stable condition.
Consistent with ABIOMED’s established policy for the AbioCor clinical trial, no further patient information will be released at this time. Additional information will be available when the clinical team and the patient’s family deem it is appropriate.
A product of three decades of research, the AbioCor is the subject of an initial clinical trial that began when the first patient was successfully implanted in July 2001. Candidates for the clinical trial must suffer from biventricular heart failure, be ineligible for heart transplantation and not able to be helped by any other available therapy, and have a high probability of dying in less than 30 days. ABIOMED has announced its intention to seek initial FDA market approval this year for the AbioCor to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”) is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED, which currently sells the BVS® 5000 Biventricular Support System and the AB5000™ Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. The company’s AbioCor® Implantable Replacement Heart is the subject of an initial clinical trial being conducted under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial.