TUCSON, Ariz., Jan. 7, 2014 /PRNewswire/ -- With 161 SynCardia temporary Total Artificial Hearts implanted in 2013, nearly double the 81 implants performed in 2011, SynCardia Systems, Inc. is on track to exceed 200 implants of the Total Artificial Heart in 2014, the company announced today.
"We expect demand to continue to accelerate this year," says Michael P. Garippa, SynCardia CEO and President. "The SynCardia Heart saves patients dying of heart failure and the Freedom® portable driver provides patients without human hearts a life worth living outside the hospital." The driver significantly improves the patient's quality of life and eliminates most in-hospital cost for this portion of the patient's care, Garippa added.
A record 286 SynCardia Total Artificial Heart implants were performed in 2012 and 2013, SynCardia Systems, Inc. noted in announcing its year-end figures. More than 1,250 SynCardia Hearts have been implanted worldwide, accounting for more than 335 patient years on the device.
Currently approved as a bridge to transplant, the longest a patient was supported by the SynCardia Heart was nearly four years prior to his successful transplant. The SynCardia Total Artificial Hearts are available at 94 SynCardia Certified Centers with another 37 in the process of certification.
Developments that SynCardia expects to see in 2014 include
- FDA approval of the Freedom portable driver that will make it available to all SynCardia Heart patients who are clinically stable for hospital discharge. It currently is approved and available without regulatory delay in Canada and Europe. More than 160 patients worldwide have used the Freedom wearable driver to power their SynCardia Heart, including over 90 U.S. patients under a clinical trial approved by the FDA.
- Introduction of a 50cc Total Artificial Heart through an FDA-approved clinical study. The smaller Total Artificial Heart, together with the current 70cc size, is designed to fit almost all women and men, as well as many pediatric patients. The smaller heart is intended to serve patients as young as 10 and with a weight as low as 70 pounds.
- Continued work with the FDA to secure a Humanitarian Device Exemption (HDE) approval to use the SynCardia Heart as a "destination therapy" (permanent use) device. The SynCardia Heart has already been designated as Humanitarian Use Device (HUD) for such destination therapy by the FDA.
The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.
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, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,250 implants of the Total Artificial Heart, accounting for more than 335 patient years of life on the device.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 94 SynCardia Certified Centers worldwide with 37 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
Forbes Ranks SynCardia #69 Among "America's Most Promising Companies"
In its February 2013 issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. See the full list of SynCardia Awards & Recognition.
SOURCE SynCardia Systems, Inc.