- Pressemitteilung BoxID 530141
SynCardia's Record-Setting Q2 Marks 5th Consecutive Profitable Quarter
Total Artificial Heart Manufacturer Preparing to Submit / Premarket Approval Supplement to the FDA for the Freedom® Portable Driver http://www.syncardia.com
"Although many companies in the mechanical circulatory support space are struggling to be profitable, SynCardia has posted its best six months and trailing 12 months in company history for sales, implants and profits," said Michael Garippa, Chairman/CEO/President. "More implants of the SynCardia temporary Total Artificial Heart have been performed in the first half of 2012 than all 12 months of 2009. We are also in the final steps of submitting our Premarket Approval Supplement to the FDA for the Freedom® portable driver."
On April 24, 2012, SynCardia completed the minimum enrollment required by the FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom portable driver. Weighing 13.5 pounds, the Freedom portable driver is the world's first wearable power supply for the SynCardia Total Artificial Heart. Worldwide, the Freedom driver, which is also CE approved for use in Europe, has supported more than 90 patients, accounting for more than 34 patient years of support.
In July, SynCardia announced that among the top 50 centers honored in U.S. News & World Report's "Best Hospitals" listfor cardiology and heart surgery, 25 have added or are in the process of adding the SynCardia Total Artificial Heart to their programs. In April 2012, the number of hospitals that have completed or enrolled in SynCardia's four-phase certification program surpassed 100. There are currently 68 SynCardia Certified Centers worldwide, spanning 15 countries.
In June, 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."
In May, the Freedom® portable driver was selected as the Bronze Winner in the Critical Care and Emergency Medicine category of the 2012 Medical Design Excellence Awards (MDEA) in Philadelphia.
CAUTION - The Freedom portable driver is an investigational device, limited by United States law to investigational use.
Über SynCardia Systems Inc
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. Similar to a heart transplant, the SynCardia temporary 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.
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 over 1,000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle.
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.
For additional information, please visit: http://www.syncardia.com
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