TUCSON, Ariz., Aug. 23, 2012 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that Michelle Johnson, a 39-year-old mother of three who received the SynCardia temporary Total Artificial Heart in January, is featured in the cover story of U.S. News & World Report’s “Best Hospitals” issue. The 2012-2013 guidebook to the nation’s top hospitals hits newsstands on Aug. 28.
(Photo: http://photos.prnewswire.com/prnh/20120823/LA61658)
The cover article, titled “Story of a Heart Transplant,” takes readers inside the operating room to explore the latest, cutting-edge cardiac technology. The story opens with Johnson and the SynCardia Total Artificial Heart, followed by a transcatheter aortic valve replacement, a mitral valve repair performed using the robotic da Vinci Surgical System and a heart transplant.
Johnson was implanted with the SynCardia Total Artificial Heart on Jan. 16. Prior to receiving the Total Artificial Heart, her body had been rejecting the donor heart she’d received on Dec. 31, 2010.
“The SynCardia Total Artificial Heart is the only device that allows the surgeon to remove the failing donor heart and bridge the patient to a second heart transplant without immunosuppressant medication,” said Michael Garippa, SynCardia Chairman/CEO/President.
Two months after receiving the Total Artificial Heart, on March 15, Johnson was discharged from the hospital to wait for a matching donor heart at home using the Freedom® portable driver. Weighing 13.5 pounds, the Freedom driver is the world’s first wearable power supply for the 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. “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 Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. On April 24, SynCardia completed the minimum enrollment required by the study. Johnson is one of 30 study participants whose data will be reviewed by the FDA in order to determine if the Freedom portable driver should be approved for commercial use.
Among the top 50 hospitals honored by U.S. News for cardiology and heart surgery, 25 have added or are in the process of adding the SynCardia Total Artificial Heart to their programs. In addition, among the “Best Children’s Hospitals” for cardiology and heart surgery were three pediatric centers that offer the SynCardia Total Artificial Heart.
CAUTION The Freedom portable driver is an investigational device, limited by United States law to investigational use.
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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 270 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. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
SynCardia Wins Two Gold Stevies® at 2012 American Business Awards
On June 18, 2012, SynCardia was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won “Company of the Year Health Products and Services” and “Most Innovative Company of the Year up to 100 Employees.” See the full list of SynCardia Awards & Recognition, which includes accolades from Forbes, Fast Company and more.
SOURCE SynCardia Systems, Inc.
