Press Release:

Evgenij V. Potapov M.D., German Heart Institute Berlin (DHZB)

TUCSON, Ariz. – March 18, 2009 – On March 3, SynCardia Systems Inc., published a press release quoting a recent article in the Journal of Heart and Lung Transplantation (JHLT) authored by Evgenij V. Potapov M.D., and the German Heart Institute Berlin (DHZB). In the background section of the article, it stated “right ventricular (RV) dysfunction develops in 20% to 50% of patients after LVAD implantation.”

“The 20-50% rate of RV dysfunction in the background section of our article was taken from a review of published clinical articles documenting the experience of several hospitals across the world from the years 1997-2008, not from DHZB,” explained Dr. Potapov, who provided the references listed below.

• 33% Tricuspid annular motion as a predictor of severe right ventricular failure after left ventricular assist device implantation. Puwanant S, Hamilton KK, Klodell CT, Hill JA, Schofield RS, Cleeton TS, Pauly DF, Aranda JM Jr.J Heart Lung Transplant. 2008 Oct;27(10):1102-7.
  
  
• 35% The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. Matthews JC, Koelling TM, Pagani FD, Aaronson KD.J Am Coll Cardiol. 2008 Jun 3;51(22):2163-72.
  
  
• 39% Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure. Dang NC, Topkara VK, Mercando M, Kay J, Kruger KH, Aboodi MS, Oz MC, Naka Y.J Heart Lung Transplant. 2006 Jan;25(1):1-6. Epub 2005 Dec 9.
  
  
• 15-26% Device and patient management in a bridge-to-transplant setting. El-Banayosy A, Körfer R, Arusoglu L, Kizner L, Morshuis M, Milting H, Tenderich G, Fey O, Minami K.Ann Thorac Surg. 2001 Mar;71(3 Suppl):S98-102; discussion S114-5.
  
  
• 33% Bridge experience with long-term implantable left ventricular assist devices. Are they an alternative to transplantation? Oz MC, Argenziano M, Catanese KA, Gardocki MT, Goldstein DJ, Ashton RC, Gelijns AC, Rose EA, Levin HR.Circulation. 1997 Apr 1;95(7):1844-52.

In the results section of the article, Dr. Potapov wrote that the overall incidence of RV failure at DHZB during the study period was 17%. “After using the special algorithm for patient selection described in the paper, we have now decreased our RV failure down to 10-12%,” explained Dr. Potapov

To read the JHLT abstract, please visit:
http://www.jhltonline.org/article/S1053-2498(08)00642-6/abstract

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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