Clinical Monitoring in Artificial Heart Study is Demanding; Trial is Assessing Safety and Effectiveness of ABIOMED's AbioCor Mechanical Replacement Heart.

Business Editors and Health/Medical Writers

CAMBRIDGE, Mass.--(BW HealthWire)--Aug. 13, 2001

The implantation of a new kind of artificial heart in a patient in Louisville, Kentucky last month was preceded by complex preparations behind the scenes concerning how to evaluate its safety and effectiveness. Abt Associates Clinical Trials (AACT), a division of Abt Associates Inc., has been working with ABIOMED, Inc. (NASDAQ:ABMD) to provide clinical and data management services for the initial clinical trial of the AbioCor(TM) Replacement Heart. The world's first fully implantable mechanical replacement heart device, the AbioCor is intended for individuals who have irreversible, life-threatening biventricular heart failure and a life expectancy of less than 30 days. At least four, and up to fourteen, more patients will be implanted with the AbioCor device in the initial clinical trial in order to assess its safety and effectiveness and its impacts on patients' quality of life.

Groundbreaking Achievement

About a year ago, AACT and ABIOMED, Inc., the Danvers, Massachusetts developer of the artificial heart, discussed the possibility of AACT conducting many of the tasks for the AbioCor Replacement Heart clinical trial. After careful consideration, ABIOMED selected AACT to participate in the study. Selection of AACT was based on the Cambridge, Massachusetts organization's expertise, staff capacity, and ability to do a wide range of tasks in connection with the study, including clinical and data management, and health economic and quality of life outcomes research.

Abt Associates Clinical Trials Division Vice President Steven Fosburg remarks, "We are supremely aware of the complexities - medical, psychological, and ethical - involved in assessing the results of replacing nature's life-sustaining pump with a mechanical device. Our selection by ABIOMED to conduct this clinical trial is confirmation of the sensitivity, care, quality, and expertise for which Abt Associates Clinical Trials is known."

Requirements Challenging

For the AbioCor artificial heart trial, the monitoring requirements go "considerably above and beyond those normally required for a medical device," remarks Inder Kaul, M.D., M.P.H., AACT's Vice President and Executive Director of Clinical Operations and Medical Affairs. "They certainly are the most challenging I have seen in the more than 200 clinical trials in which I have been involved." For example, these patients require many different medical services, generating data from numerous sources, all of which must be coordinated efficiently and quickly.

Clinical Study Team Responsible for Monitoring Practices and Progress

The job of the AACT clinical study team is to monitor the patient in the clinical setting, evaluate whether the study is being run the way that ABIOMED, AACT, and the clinical investigator have agreed upon, assess whether the FDA's Good Clinical Practices are being followed, and see that the information on the patient is being collected correctly and in a way that can be independently validated. The information gathered for this trial requires heavy interaction with not only the core team of surgeons, other physicians, and nurses immediately involved in the patient's care, but also any other service of the hospital that might provide care to the patient. The AACT team is then responsible for organizing and passing on this information to ABIOMED for use in evaluating the results of the trial.

Improvement in Quality of Life a Goal

The innovative AbioCor device is expected to improve the patient's quality of life. Patients receiving it will not be wired to a console and will not have wires coming through their skin, thus increasing their mobility and reducing their risk of infection as compared with the Jarvik 7, the last artificial heart tried twenty years ago. Abt Associates Clinical Trials has considerable experience in assisting with quality of life measurement in persons with life-threatening illness. It has a long history of conducting health economic and quality of life studies and is well-published in the field.

It is estimated that each year in the U.S. approximately 100,000 patients could benefit from a heart replacement device, as there are only about 2,500 qualified donor hearts available annually.

Abt Associates' Global Reach

Abt Associates Inc. is a private, employee-owned global company that performs social, demographic, economic, and policy research, as well as business research and consulting and clinical studies. Its regular staff of 1000 employees are located in three Massachusetts offices in Cambridge, Lexington, and Amherst; and offices in Bethesda, Maryland; Washington, D.C.; Old Greenwich, Connecticut; Chicago, Illinois; Cairo, Egypt; and Johannesburg, South Africa.

Note to Editors: The complete name of the company mentioned throughout this press release is correctly represented as "Abt Associates Inc." (upper and lower case, without a comma). It may also be represented as "Abt Associates," but not "ABT," "Abt," or "ABT Associates." For more information on Abt Associates, please visit our Web site at http://www.abtassociates.com.