TUCSON, Ariz., Aug. 15, 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 Evangelischen und Johanniter Klinikum Niederrhein (EJK Duisburg) in Germany has become one of the most active SynCardia Certified Centers in Europe.
"End-stage biventricular heart failure is a lethal disease," said Prof. Dr. med. Gero Tenderich. "Previously, treatment for this condition was limited to heart transplantation. However, this therapy is currently being challenged by an increasing shortage of suitable donor hearts and an aging society. The SynCardia temporary Total Artificial Heart achieves excellent results as a bridge to transplantation for survival, end-organ recovery and quality of life. As a highly specialized, high-volume transplant center, we consider implantation of the Total Artificial Heart for both chronic and acute cases."
On March 2, 53-year-old Ralf Becker became the first Total Artificial Heart patient at EJK Duisburg to be discharged from the hospital using the Freedom® portable driver. Weighing approximately 6 kg, the Freedom driver is the world's first wearable power supply for the SynCardia Total Artificial Heart.
"I can climb the stairs to our apartment on the third floor with almost no problem," said Mr. Becker. "Twice daily I ride for half an hour on the bicycle, and twice a week I do physical therapy. When your family stands behind you, each new day is a gift."
Mr. Becker was implanted with the Total Artificial Heart on Jan. 20, just 10 days after suffering a severe heart attack. On July 1, he and his wife Silvia, who have three children, celebrated their 24th wedding anniversary.
On June 9, 63-year-old Total Artificial Heart patient Friedhelm Rosheim was discharged from EJK Duisburg to wait for a matching donor heart at home using the Freedom driver. Since his discharge, Mr. Rosheim says he has been able to jog, climb stairs, go cycling and go out to dinner with his family.
"Mr. Rosheim and Mr. Becker have experienced an exciting improvement in quality of life," said Prof. Dr. med. Tenderich. "Walking, riding a bicycle and going out to eat with family and friends are all possible due to the small size and simple handling of the Freedom portable driver. Their trust in God and medicine keeps them going."
Worldwide, the Freedom driver has supported more than 90 patients accounting for more than 34 patient years of support. 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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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.