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Senior Citizen Health & Medicine
Critically Ill Heart Patients Now Have Permanent
Artificial Heart Option
 FDA approves totally implantable AbioCor for
Humanitarian Use
September 5, 2006 Patients with advanced heart
failure and facing death in a matter of weeks, now have available a
life-saving totally implantable artificial heart that has shown in
clinical studies to not only prolong life but also improve the quality
of life for these critically ill patients.
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Health & Medicine |
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The U.S. Food and Drug Administration today
approved the AbioCor Implantable Replacement Heart for patients with
advanced heart failure involving both pumping chambers of the heart
under the Humanitarian Use Device (HUD) provisions of the Food, Drug and
Cosmetic Act.
The device is made by Abiomed, Inc. (Danvers,
Mass.) and is intended for people who are not eligible for a heart
transplant and who are unlikely to live more than a month without
intervention.
Abiomed, announced on August 23 it had received
Humanitarian Device Exemption (HDE) approval from the FDA for AbioCor.
"This device represents a significant advance in
artificial heart technology and holds promise for critically ill heart
patients who are not candidates for heart transplants due to age or
other medical conditions," said Daniel Schultz, M.D., Director, Center
for Devices and Radiological Health, FDA. "We hope today's approval will
encourage the continued development of potentially life-saving
technologies for critically ill patients."
The AbioCor system consists of: a two-pound
mechanical heart that takes over the pumping function of the diseased
heart, which is removed during the implantation procedure; a power
transfer coil that powers the system across the skin and recharges the
internal battery from the outside; and a controller and an internal
battery, which are implanted in the patient's abdomen.
The controller monitors and controls the
functioning of the device, including the pumping rate of the heart. The
internal battery allows the recipient to be free from all external
connections for up to one hour. The system also includes two external
batteries that allow free movement for up to two hours. During sleep and
while batteries are being recharged, the system can be plugged into an
electrical outlet.
In order to receive the artificial heart, in
addition to meeting other criteria, patients must undergo a screening
process to determine if their chest volume is large enough to hold the
device.
57,000 Die Annually from Chronic Heart Failure
According to the American Heart Associations 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.
Devices approved under the HUD provisions are those
intended to treat conditions or diseases that affect fewer than 4,000
people a year in the United States, according to the FDA. Similar to the
Orphan Drug Act, the HUD provisions was designed to encourage
development of innovative medical devices to treat rare conditions. It
allows medical devices to be approved for market if they demonstrate
safety and probable benefit.
FDA based approval on the company's laboratory and
animal testing and on a small clinical study of 14 patients conducted by
Abiomed. The study showed that the device is safe and has likely benefit
for people with severe heart failure whose death is imminent and for
whom no alternative treatments are available.
One test patient was released from hospital
In some cases the device extended survival by
several months, allowing the patients to spend valuable time with family
and friends. In two cases, the device extended survival by 10 and 17
months respectively, and one patient was discharged from the hospital to
go home.
"FDA recognizes that not all patients who are
eligible will choose this option, but for many patients faced with
death, the chance to have additional time with family and
friends-however limited-is a chance they are willing to take," said
Schultz. "We believe it is important to make the latest technology
available as soon as possible and give patients and families complete
information about the risks and benefits so they can make an informed
choice."
FDA is requiring the company to provide a
comprehensive patient information package to patients and families that
clearly describes the risks as well as the probable benefits of the
device and explains what patients should expect before, during and after
surgery. The patient and physician materials are available on the
company's website at www.abiomed.com.
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. 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.
To further refine and improve the use of this
artificial heart technology, Abiomed will continue to do additional
laboratory studies and will also conduct a post-marketing study of 25
additional patients. The post-market study was recommended by the
Circulatory Systems Devices Panel, a part of the agency's Medical
Devices Advisory Committee.
"The National Heart, Lung, and Blood Institute (NHLBI)
is proud to have supported the research which led to this development,"
said Elizabeth G. Nabel, M.D., Director, NHLBI, National Institutes of
Health. "It represents a major technological advance and will benefit
people in critical need."
For more information on HUDs, visit
www.fda.gov/cdrh/ode/guidance/1381.html.
About Abiomed
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 currently manufactures and sells the AB5000
Circulatory Support System and the BVSฎ 5000 Biventricular Support
System for the temporary support of all patients with failing but
potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLAฎ
RECOVERฎ minimally invasive cardiovascular support systems under CE Mark
approval. The IMPELLA products are not yet available for sale in the
United States. The Companys AbioCor Implantable Replacement Heart was
the subject of an initial clinical trial 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. For
additional information please visit:
www.abiomed.com.
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