N O T E : The New England Journal of Medicine has placed an embargo on this information until 5 p.m. ET today (Wednesday, Aug. 25).
N O T E : The New England Journal of Medicine has placed an embargo on this information until 5 p.m. ET today (Wednesday, Aug. 25).
The study concluded that the device prevents death in critically ill patients suffering from irreversible failure of both sides of the heart who are candidates for heart transplantation.
Of the patients involved in the study, those who received the CardioWestTM had a one-year survival rate of 70 percent, compared with 31 percent for patients who did not receive the artificial heart, the study reported.
The study's lead author was Dr. Copeland, a professor of surgery and a co-director of the Sarver Heart Center at the University of Arizona College of Medicine. Dr. Copeland is a world leader in cardiac transplantation, as well as in the development of artificial heart devices.
"This study represents the culmination of nine years of research and data, and we were thrilled that the device was recommended for approval, with conditions, by the FDA Circulatory Systems Devices Advisory Panel in March," said Marvin J. Slepian, MD. Dr. Slepian is a clinical professor of medicine at the University of Arizona College of Medicine and a member of the UA Sarver Heart Center. He also is president and CEO of SynCardia Systems, Inc., the company that owns the CardioWestTM technology.
"This is a significant milestone not only for the company and for patients and their families, but also a huge step in medical history," he said.
The purpose of the study was to establish the safety and efficacy of the CardioWestTM in transplant-eligible patients at risk of imminent death from irreversible biventricular cardiac failure. The results conclusively showed that the device reduced mortality and afforded clinical stabilization for these patients.
The centers involved in the study were University Medical Center; Loyola Medical Center, in Chicago; LDS Hospital, in Salt Lake City; Saint Luke's Medical Center, in Milwaukee; and University of Pittsburgh Medical Center. The study was initiated in 1993 and concluded in 2002.
In addition to Drs. Copeland and Slepian, the study's other authors (all of the University of Arizona) were: Richard G. Smith, director of UMC's Marshall Foundation Artificial Heart Program; Francisco A. Arabía, MD, associate professor of surgery; Paul E. Nolan, PharmD, professor of pharmaceutical sciences and professor of pharmacy practice and science; Gulshan K. Sethi, professor of surgery; Pei H. Tsau, MD, assistant professor of clinical surgery; and Douglas McClellan, an engineer with the Artificial Heart Program.
About the CardioWestTM Total Artificial Heart
The CardioWestTM is a pneumatic (air-driven), biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart in patients at imminent risk of death. The device offers full circulatory support, the shortest blood path and exposure to artificial surfaces, and the highest level of cardiac output when compared with other artificial heart systems previously tested. With the CardioWestTM TAH, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of non-device cardiac recipients.
About SynCardia Systems, Inc. Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement and assist devices. SynCardia Systems is based in Tucson, Ariz., and is on the Web at www.syncardia.com. Contacts: Lauren Arnold or Kristina Ebenius, Schwartz Communications, (781) 684-0770.
