SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. The company was formed in 2001 by world-renowned heart surgeon Jack G. Copeland, MD, interventional cardiologist Marvin J. Slepian, MD, and biomedical engineer Richard G. Smith, MSEE, CCE, to commercialize the SynCardia temporary Total Artificial Heart.
Regulatory approvals for the Total Artificial Heart:
European CE Mark: Sept. 10, 1999
FDA: Oct. 15, 2004
Health Canada: Oct. 27, 2005
70cc SynCardia temporary Total Artificial Heart
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for patients suffering from end-stage heart failure affecting both sides of their heart (biventricular failure).
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers.
During the 10-year pivotal clinical study which resulted in FDA approval, 79% of near-death patients who received the Total Artificial Heart were bridged to transplant. This is the highest bridge-to-transplant rate of any approved device in the world.
HUD Designation for Permanent Use
In 2012, the FDA approved a Humanitarian Use Device (HUD) designation for the SynCardia Total Artificial Heart to be used for destination therapy (permanent use) in addition to its current approval as a bridge to transplant.
The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for the 70cc Total Artificial Heart. Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not transplant-eligible to receive the 70cc Total Artificial Heart on a permanent basis.
Freedom from the Hospital
In 2010, SynCardia introduced the Freedom® portable driver, the world’s first wearable power supply for the Total Artificial Heart. Weighing 13.5 pounds (~6 kg), the Freedom portable driver allows stable Total Artificial Heart patients who meet discharge criteria to wait for a matching donor heart at home and in their communities instead of in the hospital.
The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. On April 24, 2012, SynCardia completed the minimum enrollment required by the clinical study. On Feb. 14, 2013, SynCardia submitted the data to the FDA, which will determine if the Freedom driver should be approved for commercial use.
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
50cc Total Artificial Heart
The 50cc Total Artificial Heart is designed for use in patients of smaller stature, including women and adolescents, who have a Body Surface Area (BSA) between 1.2 and 1.79m².
HUD Designation for Permanent Use
On Jan. 15, 2013, the FDA approved a HUD designation for the 50cc Total Artificial Heart to be used for destination therapy in patients who are not eligible to receive a heart transplant.
HUD Designation for Pediatric Bridge to Transplant
On Jan. 30, 2013, the FDA approved a HUD designation for the 50cc Total Artificial Heart to be used for the treatment of biventricular heart failure in pediatric patients with a BSA that can sufficiently accommodate the device (i.e. between 1.2 and 1.7m²).
The next step is for the FDA to approve a HDE application for each indication of the 50cc Total Artificial Heart. Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart on a permanent basis as destination therapy, and an additional 4,000 pediatric patients to receive the device as a temporary bridge to transplant.
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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