Tucson, Ariz. (PRWEB) October 11, 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 revenue and implants for the first nine months of 2012 have exceeded the company’s best 12-month totals to date. The quarter ended Sept. 30 marks SynCardia’s sixth consecutive profitable quarter.
“Worldwide, SynCardia Certified Centers have performed nearly 100 implants of the SynCardia temporary Total Artificial Heart in 2012, which greatly exceeds any previous 12-month period,” said Michael Garippa, SynCardia Chairman/CEO/President. “To date, the Freedom® portable driver has supported 53 Total Artificial Heart patients in the U.S. and more than 100 patients worldwide. In Q4, we will submit a Premarket Approval Supplement for the Freedom driver to the FDA.”
Weighing 13.5 pounds, the Freedom portable driver allows stable Total Artificial Heart patients who meet discharge criteria to leave the hospital and resume their lives at home and in their communities while they wait for a matching donor heart. 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.
SynCardia’s continuing success is evident in the 2012 U.S. News & World Report “Best Hospitals” issue published in August, which features Total Artificial Heart patient Michelle Johnson in its cover story. Among the top 50 centers honored in the “Best Hospitals” issue for cardiology and heart surgery, 25 have added or are in the process of adding the Total Artificial Heart to their programs. In addition, three pediatric centers that offer the Total Artificial Heart were honored among the Top 10 “Best Children’s Hospitals” for cardiology and heart surgery.
There are currently 70 SynCardia Certified Centers worldwide spanning 15 countries, with an additional 29 hospitals currently undergoing SynCardia’s certification process.
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.