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SOURCE: SynCardia Systems, Inc.
SynCardia Certified Centers Perform Record Number of Total Artificial Heart Implants
Tucson, Ariz. (PRWEB) May 17, 2012
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced record-setting revenue for the quarter ended March 31, 2012, due in part to Certified Centers performing a record number of implants of the SynCardia temporary Total Artificial Heart.
“Q1 was our best quarter to date,” said Michael Garippa, SynCardia Chairman/CEO/President. “Compared to the same quarter last year, revenue and implants increased by more than 60%. We also set a new record for implants performed in a single quarter.”
Last month, SynCardia recognized three hospitals for their rapid use of the Total Artificial Heart: Texas Heart Institute, which performed its first four implants in 12 days, University of Washington Medical Center, which performed its first four implants in 35 days, and EJK Duisburg in Germany, which performed three implants in 20 days. In February, the Total Artificial Heart surpassed more than 1,000 implants worldwide.
“Our sales were bolstered by new hospitals that identified multiple candidates for the Total Artificial Heart and then implanted these gravely-ill patients in rapid succession,” Garippa said. “These centers have continued to deploy the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure.”
In April, the number of hospitals that are enrolled in or have completed SynCardia’s four-phase certification program surpassed 100. Of these hospitals, 68 have performed their first proctored implant of the Total Artificial Heart to become SynCardia Certified Centers, which now span 15 countries around the world.
Some of the newest SynCardia Certified Centers are pediatric hospitals. In March, Children's Hospital of Philadelphia (CHOP) and Phoenix Children’s Hospital bridged their first patients to transplant with the Total Artificial Heart. This marked three consecutive pediatric patients bridged to transplant with the Total Artificial Heart during a six-month period.
On March 2, the U.S. Food and Drug Administration (FDA) approved 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. The next step is for SynCardia to submit a Humanitarian Device Exemption (HDE) to the FDA. Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not transplant-eligible to receive the Total Artificial Heart on a permanent basis.
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 250 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 and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. 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.
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