DANVERS, Mass., July 27 /PRNewswire-FirstCall/ -- ABIOMED, Inc. today announced that the 14th patient to receive the AbioCor(R) Implantable Replacement Heart in a procedure performed May 24th by a Jewish Hospital/University of Louisville medical team has surpassed the milestone of 60 days on support.
The patient is currently in stable condition, according to Drs. Laman Gray and Rob Dowling, lead investigators for the AbioCor trial at Jewish Hospital. The 13th AbioCor patient, who was implanted on May 3rd at Jewish Hospital, continues to recover and is focusing on physical and nutritional rehabilitation, the doctors added.
Prior to the implant of the AbioCor, both patients had an expected survival of less than two weeks and suffered from bi-ventricular heart failure. Since the procedures, one patient has been able to celebrate his 35th wedding anniversary.
ABIOMED will continue its policy of making more specific patient information available only at the discretion of the patient and patient's family.
Candidates for the clinical trial must suffer from bi-ventricular heart failure, be ineligible for heart transplantation at the time of screening 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(R) 5000 Biventricular Support System and the AB5000(TM) 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(R) 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.
Media Contact: Andrea tenBroek Communications Specialist (978) 646-1815 mediarelations@abiomed.com Investor Relations Contact: Edward E. Berger, Ph.D. Vice President for Policy, Reimbursement and External Relations (978) 646-1814 ir@abiomed.com
ABIOMED, Inc.CONTACT: Media Contact: Andrea tenBroek, Communications Specialist,+1-978-646-1815, mediarelations@abiomed.com, or Investor Relations Contact:Edward E. Berger, Ph.D., Vice President for Policy, Reimbursement and ExternalRelations, +1-978-646-1814, ir@abiomed.com, both of ABIOMED
Web site: http://www.abiomed.com/