About SynCardia
SynCardia Systems, Inc. is a private company formed in 2001 to commercialize the SynCardia temporary CardioWest™ Total Artificial Heart.
Today, with more than 800 implants, the SynCardia Total Artificial Heart is the only FDA, Health Canada and CE approved Total Artificial Heart in the world. Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure.
Similar to a heart transplant, the Total Artificial Heart eliminates the symptoms and source of biventricular failure by replacing both failing heart ventricles. Unlike a donor heart, the Total Artificial Heart is instantly available at SynCardia Certified Centers. During the 10-year pivotal clinical study, 79% of patients receiving the Total Artificial Heart survived to transplant. This is the highest bridge-to-transplant rate of any approved device in the world*.
Freedom™ Driver System
Currently, U.S. Total Artificial Heart patients are confined to the hospital while they wait for a matching donor heart. Without discharge, U.S. hospitals are only reimbursed for one procedure, the subsequent heart transplant.
SynCardia has submitted an application to the FDA to conduct an IDE clinical study of the new, lightweight Freedom™ driver system^. Once approved, the clinical study is designed to demonstrate that stable Total Artificial Heart patients can leave the hospital to wait for a matching donor heart at home.
When the Freedom driver becomes available through an IDE clinical study, SynCardia anticipates that discharging stable patients will eliminate in-hospital costs for this portion of their care and allow U.S. hospitals to be reimbursed for both the Total Artificial Heart implant and the subsequent heart transplant.
Pulsatile Product Pipeline
SynCardia is also developing a family of pulsatile devices, including: the 50cc Total Artificial Heart for patients of smaller stature, 10cc and 30cc ventricular assist devices (VADs) for newborns and small children and the 60cc VAD for adults. The Companion Driver System†, which is approved for use in Europe and has been submitted to the FDA, is designed to power all SynCardia pulsatile products.
*The pivotal clinical study of the SynCardia Total Artificial Heart used two endpoints: bridged-to-transplant and death. Recent pivotal clinical studies of approved ventricular assist devices state a success rate that includes: patients alive and transplant-eligible at 6 months, patients who recovered and patients who were bridged-to-transplant.
Sources:
SynCardia Total Artificial Heart FDA Summary of Safety and Effectiveness, pages 8 & 9 http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf ›› download
HeartMate II FDA Summary of Safety and Effectiveness, page 12 http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf ›› download
^CAUTION – The Freedom™ driver system is an investigational device, limited by United States and EU law to investigational use.
†CAUTION – The Companion Driver System is an investigational device limited by United States law to investigational use. It is CE approved for use in Europe. It is not FDA approved for use in the U.S.
The Total Artificial Heart fulfills a role that no other mechanical circulatory support device can for patients in irreversible biventricular failure.”
Centers for Medicare &
Medicaid Services (CMS)
– July 31, 2008
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