TUCSON, Ariz., Feb. 14, 2013 /PRNewswire/ -- SynCardia Systems, Inc. ( www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE ( Europe) approved Total Artificial Heart, has been selected by Forbes 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 ranked #69, moving up eight spots from its #77 ranking last year.
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"2012 was a record-breaking year for the SynCardia temporary Total Artificial Heart with a 200% increase in implants over 2010 and over 400% revenue growth since 2009," said Michael Garippa, SynCardia Chairman/CEO/President. "That momentum has continued into the new year with year-to-date implants representing a 40% increase over the same time period last year. In addition, this week we will submit our premarket approval supplement to the FDA for the Freedom® portable driver."In 2012, SynCardia achieved several regulatory milestones, including:
- Completing the required patient enrollment in the FDA-approved Investigational Device Exemption (IDE) clinical study of its Freedom portable driver, the world's first wearable power supply for the SynCardia Total Artificial Heart
- FDA approval of a Humanitarian Use Device (HUD) designation for the Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant
- FDA approval of the Companion 2 Hospital Driver for supporting patients from implant of the Total Artificial Heart until their condition stabilizes