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SynCardia Systems, Inc.

Press Release:

Successful Artificial Heart Pursued by Many, Achieved by One

New SynCardia Website Features World’s 1st and Only FDA, Health Canada and CE Approved Total Artificial Heart

While there have been hundreds of artificial heart designs, only one artificial heart has withstood the rigors of the human body and regulatory approval… the SynCardia Total Artificial Heart. Today, it is the world’s only FDA, Health Canada and CE approved Total Artificial Heart. While there have been hundreds of artificial heart designs, only one artificial heart has withstood the rigors of the human body and regulatory approval… the SynCardia Total Artificial Heart. Today, it is the world’s only FDA, Health Canada and CE approved Total Artificial Heart. TUCSON, Ariz. – Jan. 19, 2010 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, has announced the launch of its new website (www.syncardia.com) to educate visitors that the artificial heart isn’t science fiction: it’s real, it works and it’s saving lives.

A quick search for “artificial heart” on Google News will produce a multitude of articles. Results include artificial hearts designed with aircraft technology, 13 chamber artificial hearts that mimic a cockroach heart and fully-implantable designs requiring pounds of equipment to be surgically implanted into the patient’s chest and abdomen.

Hundreds of artificial heart designs have been created, tested and ultimately shelved. Only one artificial heart has withstood the rigors of the human body and regulatory approval… the SynCardia Total Artificial Heart. Today, it is the only FDA, Health Canada and CE approved Total Artificial Heart in the world. There have been more than
800 implants accounting for more than 180 patient years.

Visitors to SynCardia’s new website will find more than double the content, including:

  • Clinical Experience: A presentation of data documenting the clinical success of the Total Artificial Heart as a bridge-to-transplant from some of the most reputable sources in medicine, including INTERMACS and the New England Journal of Medicine.
  • Patient Stories: Through their own words and personal photos, 10 patients share their experiences being bridged-to-transplant with the Total Artificial Heart.
  • Video Center: Featuring more than 20 videos, viewers can watch news stories, including a National Geographic multimedia feature, patient interviews, educational animations and more. 


SynCardia has submitted an application to the FDA to conduct an IDE clinical study in the U.S. of a new discharge driver. This wearable driver is designed to power the Total Artificial Heart outside the hospital so stable patients can wait for their matching donor heart at home. SynCardia has also applied for CE approval for use in Europe.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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