Source : SynCardia Systems, Inc.
Tucson AZ USA -- Medical E-Mail News™ / May 10 2012 -- SynCardia Systems, Inc. (http://www.syncardia.com), 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 He art. 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."
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.
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. Similar to a heart transplant, the SynCardia temporary 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.
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. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles.
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 lbs, SynCardia’s Freedom® portable driver is the world’s first wearable driver designed to p ower the Total Artificial Heart both in side 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