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Patients Recover Rapidly with the SynCardia Total Artificial Heart Safe Blood Flow Up to 9.5 Liters per Minute The Total Artificial Heart is the only device that provides immediate, laminar blood flow of up to 9.5 liters per minute through each ventricle. Implanting the Total Artificial Heart helps make patients healthier transplant candidates: n Immediately increases Cardiac Index (CI) n Immediately restores normal Central Venous Pressure (CVP) n Resuscitates kidneys, liver, GI tract, brain, other vital organs n Overcomes high Pulmonary Arterial Pressure (PAP) n Restores normal hemodynamics and organ perfusion Data from the 10-year pivotal clinical study of the Total Artificial Heart, published in the New England Journal of Medicine (N Engl J Med 2004; 351:859-867) Immediate Increase in Cardiac Index Organ Recovery at Two Weeks Prior to implant, patients in need of the Total Artificial Heart had a baseline cardiac index of 1.9 L/min/m 2 . Immediately following implant, the patient’s cardiac index increased to an average of 2.9 L/min/m 2 . Liver function had returned to normal at two weeks Kidney function had improved significantly, trending to normal Physical Recovery Bridging the Sickest Patients to Transplant Post-Operative Day 5: Approximately 65% of the core Total Artificial Heart patients were out of bed. According to March 2011 INTERMACS data, 72% of Total Artificial Heart patients were transplanted at 6 months and 75% at 12 months. Post-Operative Day 14: 60% of core Total Artificial Heart patients were walking more than 100 feet. Previous reports have shown that almost all Total Artificial Heart patients were classified in the two sickest INTERMACS categories prior to implant, yet the SynCardia Total Artificial Heart had the highest bridge to transplant rate of all the devices tracked in INTERMACS. French Total Artificial Heart patient Mr. Lediouron pictured at home with the Freedom® portable driver in Sept. 2010 with his wife Karene and their two daughters, Wendy and Sidney. In comparison, approximately 25% of patients with other mechanical circulatory support devices were classified in less sick categories prior to implant. Christian Lediouron FRANCE Implanted: May 17, 2010 Freedom® discharge: June 30, 2010 Transplanted: March 3, 2011 Highest bridge to transplant rate: Survival to transplantation was achieved in 79% of patients who received the SynCardia Total Artificial Heart according to protocol, as compared with 46% of the controls who did not receive the device. This is the highest bridge to transplant rate of any approved heart device. Overall survival: The one-year survival rate among patients who received the Total Artificial Heart was 70%, as compared with 31% among the controls. One-year and five-year survival rates after transplantation among patients who had received the Total Artificial Heart were 86% and 64%. 4 5
The SynCardia Total Artificial Heart powered by the Freedom® portable driver Left ventricular assist device (LVAD) On July 22, 2011, Shawn Galloway became the first of four patients to receive the Total Artificial Heart at Texas Heart Institute during a 12-day period. A month after her surgery, she was discharged home to wait for a matching donor heart with her husband Joel and their daughter Hannah. She received her heart transplant on Sept. 20, 2011. Shawn Galloway UNITED STATES Implanted: July 22, 2011 Freedom® discharge: Aug. 23, 2011 Transplanted: Sept. 20, 2011 CAUTION - The Freedom® portable driver is an investigational device, limited by United States law to investigational use. 6 Additional Benefits of the SynCardia Total Artificial Heart No right ventricular dysfunction/failure No acquired von Willebrand syndrome (AVWS) reported Right Ventricular Dysfunction/Failure after LVAD Implant HeartWare HVAD - ADVANCE Clinical Study Results 22% of patients developed right heart failure requiring either a Right Ventricular Assist Device (RVAD) or inotropic support* HeartMate II LVAD - Pre-Market Approval Results 19% of patients developed right heart failure during the pre-market approval of the HeartMate II** *Source: Evaluation of the HeartWare HVAD Left Ventricular Assist System for the Treatment of Advanced Heart Failure: Results of the ADVANCE Bridge to Transplant Trial; Keith Aaronson, Mark Slaughter, Edwin McGee, et al. for the HeartWare ADVANCE Investigators; American Heart Association Scientific Sessions November 2010 **Source: HeartMate II FDA Summary of Safety and Effectiveness http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf “Acquired von Willebrand syndrome in patients with ventricular assist device or total artificial heart” Authors: C. Heilmann, U. Geisen, F. Beyersdorf, L. Nakamura, C. Benk, M. Berchtold-Herz, G. Trummer, C. Schlensak, B. Zieger; University Medical Center Freiburg, Freiburg, Germany Published in Thrombosis and Haemostasis 2010 103 5: 962-967 Summary: “Unexplained bleeding episodes are associated with ventricular assist devices (VAD) and can occur in part due to acquired von Willebrand syndrome (AVWS)… We studied 12 patients who required mechanical support of their native heart for terminal cardiac insufficiency. Nine patients underwent placement of a VAD, while three underwent placement of a total artificial heart (TAH)… AVWS was present within two weeks of implantation in eight of nine patients… AVWS was not observed in the TAH patients studied. Our findings demonstrate that patients with an implanted VAD experience a rapid onset of AVWS that is quickly and completely reversed after device explantation.” Prof. Dr. Friedhelm Beyersdorf, Director of Cardiovascular Surgery at University Medical Center Freiburg, Germany
Page 2 and 3: 2 Both failing ventricles are remov
Page 6 and 7: First of 3 consecutive pediatric pa

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