|FOR IMMEDIATE RELEASE
September 5, 2006
FOR MORE INFORMATION:
Jeff Polson or Barbara Mackovic
Abiomed Receives FDA Approval of The AbioCor®, The World’s First Completely Self-Contained, Implantable Artificial Heart
AbioCor Granted Humanitarian Device Exemption
Jewish Hospital/UofL Team to Implant Additional AbioCor® Hearts
(LOUISVILLE, KY) – Abiomed, Inc. announced today it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its AbioCor® Implantable Replacement Heart (AbioCor). Jewish Hospital will again be among the first U.S. hospitals to offer patients the AbioCor totally implantable replacement heart. The Jewish Hospital/University of Louisville team principal investigators and surgeons are Laman Gray, M.D., Rob Dowling, M.D., and Sanjeev Aggarwal, M.D.
This landmark approval will provide patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative, a viable option for extending the quality of their life. The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin. This technology provides patients with complete mobility and remote diagnostics.
The AbioCor is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative. The AbioCor sustains the body's circulatory system and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. A post-market study is planned to allow Abiomed to monitor and optimize the introduction of the AbioCor into clinical use.
The FDA decision was completed after extensive review of the clinical testing, beginning with clinical trials starting in 2001 under an Investigational Device Exemption (IDE). The AbioCor would be available under an HDE to a limited patient population in the United States under this approval, with no more than 4,000 patients receiving the technology each year. In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program which may take six to eight months. Under HDE approval, the FDA may request a panel review of the post-approval study data. In addition, Abiomed is working with the Centers for Medicare and Medicaid Services (CMS) and private insurers to establish reimbursement policies for the AbioCor.
Jewish Hospital in Louisville, KY, an AbioCor clinical trial site, will be among the first U.S. hospitals to offer patients the AbioCor. The Jewish Hospital/University of Louisville team, led by surgeons Laman Gray, M.D., and Rob Dowling, M.D., performed the first and second AbioCor implantable replacement heart procedures in the world and a total of seven implants since 2001. The longest surviving patient, Tom Christerson, lived 17 months with the artificial heart.
Two other hospitals are entering into a letter of intent. They are: The Johns Hopkins Hospital in Baltimore, MD, with Dr. John Conte, and Robert Wood Johnson University Hospital in New Brunswick, NJ, with Dr. Mark Anderson.
"The AbioCor has the potential to fill a very real void. Patients in bi-ventricular heart failure who were not candidates for a heart transplant often do not have adequate support with drug therapy or even other destination-therapy ventricular assist devices that are designed to boost only one side of the heart. Now we can continue to treat these severely ill heart failure patients," said Dr. Laman Gray, Jr., Professor of Surgery and Director of the Division of Thoracic and Cardiovascular Surgery at the University of Louisville School of Medicine.
According to the American Heart Association's 2006 Statistics, each year 57,000 patients in the United States die from chronic heart failure. While roughly 2,200 donor hearts are transplanted into patients suffering from heart failure, there are many more patients awaiting a second chance at life, for whom a heart transplant is not an option. Patients with advanced age, organ failure or cancer are, in most circumstances, ineligible for a heart transplant and are potential candidates to receive the AbioCor implantable heart. The Humanitarian Device Exemption (HDE) approval of the AbioCor signifies that no comparable alternative therapy exists for patients facing imminent death without the technology, and that it has proven to be safe and have probable benefit for patients.
About Jewish Hospital & St. Mary’s HealthCare
Jewish Hospital & St. Mary's HealthCare (JHSMH) is a regional health care network that includes 70 health care facilities and 1,900 patients beds in Kentucky and southern Indiana. The merger of Jewish Hospital HealthCare Services and CARITAS Health Services to form JHSMH combines the strength and honors the heritages of the two organizations to provide a complete array of health care services to this region and beyond, including: hospitals, emergency air ambulance services, outpatient care, nursing home care, occupational health, psychiatric care and rehab medicine. JHSMH provides home health care to families in 41 Kentucky and southern Indiana counties, occupational health mobile services to 30 Kentucky counties and employs a network of physician practices that provide both primary and specialty medical care. The organization employs more than 8,100 people.
ABOUT THE ABIOCOR
The AbioCor® Implantable Replacement Heart is one of the most sophisticated medical devices ever developed and is designed to extend the lives of patients who would otherwise die of heart failure. The AbioCor can potentially offer an improved quality of life so that a patient can be mobile and continue a productive lifestyle. The AbioCor is the only artificial heart without wires piercing through the skin, reducing the chance of infection. Its remote diagnostics allow patients to return home where they can resume normal activities including bathing. The AbioCor is able to pump blood through the body, simulating the rhythm of a heartbeat. The complete AbioCor system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package, a power receiver coil, and externally, a power transmitter coil, power and battery pack, handheld alarm monitor and sophisticated computer console.
Abiomed continues to develop next-generation total artificial heart technology, the AbioCor II, in order to provide life-saving circulatory support to more patients in bi-ventricular heart failure. Currently in preclinical evaluation, this technology has the potential to last up to five years and is approximately 30 percent smaller than the AbioCor.