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Press Release:

Cedars-Sinai Implants 1st Total Artificial Heart
to Bridge Mother of Three to Second Heart Transplant

39-Year-Old Michelle Johnson Waiting for Matching Donor Heart at Home
with Her Children Using the Freedom® Portable Driver

 

Michelle_Johnson_1L to R: Dr. Fardad Esmailian, Rotch Delos Santos, RN, Total Artificial Heart patient Michelle Johnson and Dr. Jaime Moriguchi on March 1, 2012. Photo by Cedars-Sinai Medical Center

TUCSON, Ariz. – May 10, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, said today that Cedars-Sinai Medical Center in Los Angeles has discharged its first patient to be implanted with the SynCardia temporary Total Artificial Heart. Michelle Johnson, 39, left the hospital to wait for a matching donor heart at home using the Freedom® portable driver to power her Total Artificial Heart.

"The SynCardia Total Artificial Heart has given me one more day at life, and that day has turned into weeks and months, allowing me to become healthier for my heart transplant," said Johnson, a single mother of three. "The Freedom driver allowed me to leave the hospital and enjoy a better quality of life at home, where I'm able to see my kids and enjoy the closeness of my family. The light weight of the driver allows me to move around with little hassle or strain."

Michelle_Johnson_3On March 15, 2012, Michelle Johnson became the first Total Artificial Heart patient to be discharged from Cedars-Sinai Medical Center to wait for a matching donor heart at home using the Freedom® portable driver. She is pictured with her mother. Photo by Cedars-Sinai Medical Center

Johnson was first diagnosed with congestive heart failure in her late twenties after she sought medical attention at an emergency room for shortness of breath. Doctors placed her on medication and she started feeling better.  

However, in 2003, Johnson's doctor told her she would eventually need a heart transplant. They implanted her with a defibrillator in 2004 to help manage her worsening heart failure. Her condition continued to deteriorate and on Dec. 31, 2010, Johnson received a heart transplant at Cedars-Sinai. However, she was in and out of the hospital seven times in the next year.

"I made it almost a year with my first donor heart," she said. "But in October 2011, they started to see the signs of rejection, and on Nov. 30, 2011, I was admitted to the hospital. They tried several treatments to try to save the donor heart, but they didn't work. The doctors said my only option was to get the Total Artificial Heart."

On Jan. 16, 2012, doctors performed the hospital’s first implant of the SynCardia Total Artificial Heart to bridge Johnson to her second heart transplant. Six weeks later, Johnson’s condition had stabilized and she was switched to the 13.5-pound Freedom portable driver, the world’s first wearable power supply for the Total Artificial Heart. On March 15, she was discharged from the hospital to wait for a matching donor heart at home.

"I'm just grateful that the doctors and SynCardia have this technology available to help people like me," said Johnson. "My doctors and nurses at Cedars were a real blessing and very helpful. They treated me like they were my second family while I was away from home going through this situation."

After she receives her transplant, Johnson says she would like to go back to school so she can help educate others on getting regular checkups, eating right and exercising.

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.

CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.

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SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.

Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by over 200 patients, accounting for over 120 years of support.

 

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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