Press Release:

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.

Andrzej Bielak was bridged-to-transplant after 544 days of life with the SynCardia Total Artificial Heart. He is pictured here post-transplant with his wife Anita at their home in Backnang, Germany, holding the Total Artificial Heart.

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.

###

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 950 implants of the Total Artificial Heart, accounting for more than 230 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
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660