Tucson, AZ (PRWEB) April 26, 2012
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that retired professional hockey player and two-time Olympian, Gaetano “Gates” Orlando, has become the first person in upstate New York to receive the SynCardia temporary Total Artificial Heart. The 49-year-old, who played for the Buffalo Sabres and Rochester Americans, as well as the Italian national team in the 1994 and 1998 Olympics, received the Total Artificial Heart on April 4 at University of Rochester Medical Center (URMC).
“This is tremendous technology that can have a dramatic effect on patients who are experiencing advanced heart failure,” said H. Todd Massey, M.D., surgical director of the URMC Artificial Heart Program who led the surgery. “For this patient, it was the only option to keep him alive until a donor heart could become available.”
Last year, Orlando was diagnosed with a rare disease known as sarcoidosis, which led to heart failure and caused potentially fatal arrhythmias. Doctors placed him on medication and gave him a defibrillator to help regulate his heart rhythms. However, on March 30, while undergoing a procedure to change out the defibrillator, Orlando was struck by a life-threatening arrhythmia. Doctors placed him on extracorporeal membrane oxygenation (ECMO), which takes over the function of the heart and the lungs, and quickly made arrangements to perform their first implant of the Total Artificial Heart to save his life.
“The Total Artificial Heart leads to recovery of organ function in the most critically ill patients, allowing for a heart transplant when the patient is more stable - which ultimately helps achieve better outcomes following transplantation,” said Dr. Massey.
Just one week after the implant surgery, Orlando was sitting in a chair and taking some steps. His doctors say they expect him to be hospitalized for several more weeks before he is stable enough to be considered for discharge from the hospital.
“While we hope to perform a transplant as soon as the patient is ready, he can live with the Total Artificial Heart for a long time,” said Dr. Massey. “We hope to be able to provide our patient with the portable driver so that he can resume a reasonably normal lifestyle and activities until a donor heart becomes available.”
Weighing 13.5 pounds, the Freedom® portable driver is the world’s first wearable power supply for SynCardia’s Total Artificial Heart. It is the designed to allow stable patients to wait for a matching donor heart at home and in their communities instead of in 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.
"This is something that doesn't just extend or prolong their lives, but actually almost normalizes their quality of life and that's one of the key components to this technology and its advancement,” said transplant cardiologist Dr. Eugene Storozynsky.
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. 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.