Download PDF - SynCardia Systems, Inc.

Recommendations

Info

2 Both failing ventricles are removed. The four native valves are removed. The atria, aorta and pulmonary artery remain intact. Quick connects are sewn into the atria, aorta and pulmonary artery. The Total Artificial Heart (TAH) is implanted and attached via four quick connects. When a donor heart becomes available, the TAH and quick connects are removed. The donor heart is transplanted. For patients dying from end-stage biventricular heart failure, there are only two options: 1. An immediate donor heart transplant, availability uncertain. 2. The SynCardia temporary Total Artificial Heart as a bridge to transplant, Donor Hearts: Only 3,500 Available Worldwide Annually # of Donor Heart Transplants immediately available at SynCardia Certified Centers. 2500 – 2000 – 1500 – 1000 – 500 – US Donor Heart Transplants 0 – 90 95 00 05 10 Year Despite growing demand worldwide, only 3,500 donor hearts become available annually. It is estimated that each year, up to 100,000 people in the U.S. alone could benefit from mechanical circulatory support devices such as the SynCardia Total Artificial Heart. SynCardia Total Artificial Heart Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to transplant for transplant-eligible patients at risk of imminent death from biventricular failure. It is the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. Bridge to Second Transplant The SynCardia Total Artificial Heart is the only device that allows surgeons to remove the failing transplanted heart and stop immunosuppressant medication until a second matching donor heart can be transplanted. “I have witnessed several patients who needed a second transplantation, but died before a donor heart became available. Those patients would have been excellent candidates for an immediately-available heart. The Total Artificial Heart is the only device that allows us to remove the failing donor heart completely and bridge patients to a second transplant without immunosuppressive therapy.” David Luís Simón Morales, MD Executive Co-Director, The Heart Institute Professor and Endowed Chair of Pediatric Cardiothoracic Surgery Chief, Pediatric Cardiothoracic Surgery Cincinnati Children’s Hospital Medical Center The University of Cincinnati College of Medicine Survival (%) 100 80 60 40 20 Survival Curve After Heart Transplantation N = 66,751 # of Donor Heart Transplants Europe Donor Heart Transplants 2500 – 2000 – 1500 – 1000 – 500 – 0 – 01 02 03 04 05 06 07 08 Year 0 Years 0 4 8 12 16 21 Source: Journal of the American College of Surgery 2006; 203(2): 226-39.
Human Heart Similar to a heart transplant, the SynCardia Total Artificial Heart is the only device that: Eliminates the symptoms & source of end-stage biventricular heart failure Replaces both failing ventricles Replaces all four heart valves Eliminates native heart complications No ventricle dysfunction/failure No diseased heart valves No arrhythmias or need for pacemaker/defibrillator Provides immediate, safe blood flow up to 9.5 L/min through each ventricle Immediately restores normal Cardiac Index (CI) Immediately restores normal Central Venous Pressure (CVP) Overcomes high Pulmonary Arterial Pressure (PAP) Restores normal hemodynamics and organ perfusion Unlike a donor heart, the SynCardia Total Artificial Heart Is immediately available at SynCardia Certified Centers Does not require expensive, immunosuppressant medication, which can cause subsequent complications Mr. Okeke received his first heart transplant at age 30 after a blood clot damaged his coronary artery. Thirteen years later, his body began rejecting his donor heart and he was implanted with the Total Artificial Heart. Since receiving his second heart transplant in January 2011, Mr. Okeke has been enjoying life at home with his wife Natalie and their three young children. Charles Okeke UNITED STATES SynCardia temporary Total Artificial Heart Implanted: Sept. 3, 2008 Freedom® discharge: May 3, 2010 Transplanted: Jan. 15, 2011 CAUTION - The Freedom® portable driver is an investigational device, limited by United States law to investigational use. 3
Page 4 and 5: Patients Recover Rapidly with the S
Page 6 and 7: First of 3 consecutive pediatric pa

Download PDF - SynCardia Systems, Inc.

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?