Press Release:

INTERMACS: Total Artificial Heart Bridge-to-Transplant Rate 2x Higher
at 6 Months Than BiVADS and LVADs

Replacing Both Ventricles with the Total Artificial Heart Eliminates Complications Including Right Heart Failure

Chart 1: INTERMACS bridge-to-transplant rates at 6 months by device category

Chart 1: INTERMACS bridge-to-transplant rates at 6 months by device category

TUCSON, Ariz. – May 12, 2009 – According to INTERMACS data recently published in SynCardia’s 2008 Annual Report, the SynCardia temporary CardioWest™ Total Artificial Heart has a bridge-to-transplant rate of 72% at 6 months. This is double the bridge-to-transplant rate for Biventricular Assist Devices (BiVADS) at 36% and Left Ventricular Assist Devices (LVADs) at 27% (see Chart 1).

Unlike BiVADs and LVADs which assist the heart ventricle(s), the Total Artificial Heart replaces both dying heart ventricles. This eliminates complications caused by a dying heart including right native heart failure.

According to INTERMACS, 8% of BiVAD patients and 10% of LVAD patients experience right heart failure (see Chart 2). These patients often require treatment with inotropes and/or implantation of a right ventricular assist device. Total Artificial Heart patients are not subject to right native heart failure
because the dying heart ventricles have been removed.

Chart 2: INTERMACS rates of right heart failure by device category

Chart 2: INTERMACS rates of right heart failure by device category

INTERMACS is the US national registry for patients with mechanical circulatory support devices that treat advanced heart failure. By applying uniform definitions and standards, INTERMACS levels the playing field for all mechanical circulatory support devices. INTERMACS tracks patient survival, adverse events and cause of death over time by patient profile, device and device category.

INTERMACS was created as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the United Network for Organ Sharing (UNOS) among others.





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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.

Similar to a heart transplant, SynCardia's 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 and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660

 

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

 

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