ABIOMED Announces First FDA-Approved ABIOCOR® Implant

Jun 24 2009

DANVERS, Massachusetts -– Abiomed, Inc. (NASDAQ: ABMD), today announced the successful implant of its AbioCor® Total Replacement Heart, performed at Robert Wood Johnson University Hospital by Mark Anderson, M.D., associate professor of surgery at UMDNJ-Robert Wood Johnson Medical School and chief of the section of cardiac surgery at both the medical school and Robert Wood Johnson University Hospital. This is the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) on September 5, 2006.

The 76-year-old male patient was diagnosed with congestive, end-stage heart failure and did not qualify for a heart transplant or other available therapies, making him eligible for the AbioCor implant. More than one week after the surgery, the patient is showing signs of a strong and stable recovery.  “We are honored to be among the few distinguished institutions in the nation to offer this innovative technology to patients who have no other treatment alternatives available to them,” said Dr. Anderson.
“The implantation marks the culmination of nearly three decades of research and development and the technology has finally reached the point where an artificial heart has become a real option for endstage heart failure patients. We believe this procedure is a significant step toward offering new hope and a future to patients who may still have more quality time with their family and loved ones.”

“The AbioCor is designed to give end stage heart failure patients another treatment option to extend their quality of life when they are ineligible for all other medical therapies,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “We are thrilled to be working with the renowned Robert Wood Johnson University Hospital.”

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart.
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