Includes Data Submitted For FDA Approval Of Novacor® System
SAN FRANCISCO, April 23 -- Results of a study of more than 150 patients sustained on the Novacor® Left Ventricular Assist System (LVAS) as a "bridge" to transplantation were presented for the first time at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting today. The findings, which represent experiences of 22 U.S. transplant centers, included data that served as the basis for U.S. Food and Drug Administration (FDA) approval of the system less than a year ago. The Novacor LVAS is a product of the Cardiovascular Group of Baxter Healthcare Corporation.
Those patients who were discharged from the hospital with the Novacor LVAS while waiting for donor hearts fared better than patients whose medical condition required them to stay in the hospital, reported Robert Kormos, M.D., associate professor of surgery and director of the artificial heart and adult transplantation program at the University of Pittsburgh Medical Center (UPMC). About a third of the patients (29 percent) waited outside the hospital, six for more than a year and two for more than two years, allowing them the opportunity to lead normal, productive lives.
"The clinical experience with the discharged patients indicates there is improved quality of life and highlights the safety and feasibility for long-term use," said Dr. Kormos, a principal investigator of the multi-center trial.
With the number of patients being placed on transplant waiting lists growing
each year but the supply of available organs remaining relatively stagnant,
artificial assist devices serve a critical function by providing patients a
means to sustain heart function until human donor hearts can be found. There
are currently more than 4,200 patients on the national heart transplant waiting
list, according to the United Network for Organ Sharing, and waiting times can
exceed two or three year
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Contact: Lisa Rossi
rossiL@msx.upmc.edu
412-647-3555
University of Pittsburgh Medical Center
23-Apr-1999