For the first time in the United States, Arrow International's fully implantable left ventricular assist system has been implanted in a patient.
The implant of Arrow's LionHeart was performed for the treatment of endstage congestive heart failure by Walter Pae, Jr, MD, professor of surgery at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania. Arrow, based in Reading, said that the patient "is recovering as expected."
The LionHeart, the first fully implantable device for destination therapy, is designed to take over the entire workload of the left ventricle.
The implant is the first to be conducted by Arrow under an investigational device exemption granted by the Food and Drug Administration to test the LionHeart in phase I human clinical trials. The trial is limited to seven patients at five sites, including Hershey, the University of Pennsylvania Medical Center, the University of Arizona Medical Center, Loyola University Medical Center, and the University of Iowa Medical Center. Arrow hopes to begin a phase II trial by the end of the company's fiscal year 2001. In a statement, Marlin Miller, Jr, Arrow's chairman and chief executive officer, said: "Commencement of U.S. clinical trials is an important milestone toward providing a potential option for the estimated 40,000 U.S. patients who die each year from congestive heart failure. For CHF patients no longer responsive to medical management, the only significant treatment option available today is to qualify for one of the estimated 2,300 donor hearts available for transplant each year."
For Your Information:
See Arrow's statement at www.arrowintl.com/corporate/022801.html.
See Transplant News Network for February 15, 2001, "FDA Approves IDE for Implantable Left Ventricular Assist System."
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