In short
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, has announced revenue for the quarter ended June 30, 2012, marking the company’s best quarter to date and its fifth consecutive profitable quarter.
Background
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 Centres. Syncardia tells us 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.
Weighing 13.5 pounds, SynCardia’s Freedom portable driver is the world’s first wearable power supply for the SynCardia Total Artificial Heart. Worldwide, the Freedom driver has itself reportedly supported more than 90 patients, accounting for more than 34 patient years of support.
Company comments
“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.”
Regulatory status
The Freedom portable driver is an investigational device, limited by United States law to investigational use.
SOURCE SynCardia Systems, Inc., PR Newswire
