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… and SynCardia is understandably keen to draw our attention to it with the issuance of a press release on the subject.
SynCardia Systems, Inc., manufactures the world’s first and only FDA, Health Canada and CE mark approved Total Artificial Heart. We recently covered the news that the company’s most recent quarterly figures showed it to be growing and consistently profitable.
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.
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. 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 litres 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.
“Best Hospitals” 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.
Michelle 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.
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 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.
“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.
Source: SynCardia Systems, Inc., PR Newswire