Press Release:

Marcela Padilla, 21, pictured with her son Santiago, is the first female Total Artificial Heart patient in the U.S. to go home using the Freedom® portable driver (shown here in the Backpack) as part of an FDA clinical study.

TUCSON, Ariz. – Feb. 24, 2011 – On Jan. 20, Marcela Padilla, 21, became the first woman and the fifth person in the U.S. to leave the hospital using the Freedom® portable driver to power her SynCardia temporary Total Artificial Heart. The Tucson mom was discharged from University Medical Center (UMC) just in time to celebrate her 21st birthday at home with her husband and 9-month-old son Santiago.

"It was so exciting to go home and be with my baby," Padilla said. "I feel really good now and I can take care of my son."

Padilla is participating in an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. Currently, the only FDA-approved driver for powering the Total Artificial Heart is the 418-lb "Big Blue" hospital driver, which confines patients to the hospital until they receive a heart transplant.

Marcela Padilla is participating in an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital.

"It's a win on multiple levels," said Dr. M. Cristina Smith, director of Heart Transplant and Ventricular Assist Device Services at UMC. "[The Freedom driver] gives the patient the opportunity to be home surrounded by loved ones. The hospital and the health system also win. You don't have someone stuck in a hospital bed. The cost savings to the health care system is going to be pretty significant."  

Padilla gave birth to her son on April 25, 2010, but four days later, began to experience shortness of breath and fatigue. The pregnancy may have strained her heart, which was already weak due to a congenital condition, and she was diagnosed with cardiomyopathy. Her twin sister had received a heart transplant at age 11.

Padilla was implanted with the Total Artificial Heart on Sept. 24, 2010. Once stable, she was switched from the Big Blue driver to the Freedom portable driver. She and her family completed extensive training on use of the Freedom driver and in January, she was ready to leave the hospital to wait for a matching donor heart at home.

"We're so excited we are able to provide this first time opportunity to such a wonderful young mom and her family," Dr. Smith said. "It's just heart-warming."

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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