SynCardia Posts Best Q1 in Company History
Total Artificial Heart Manufacturer Expects Attendance to Triple
at Clinical Investigator Meeting for Freedom® Portable Driver at ISHLT
TUCSON, Ariz. – April 7, 2011 – SynCardia Systems, Inc., the privately-held manufacturer of the SynCardia temporary Total Artificial Heart, announced today that it set a new Q1 record in 2011, nearly doubling sales from its previous best Q1 in 2010.
"The company continues to pick up velocity and traction as we work to complete the FDA-approved Investigational Device Exemption clinical study of the Freedom® portable driver," said SynCardia President Michael Garippa. "In Q1, we enrolled an additional 11 patients in the U.S., discharging 6. The Freedom driver, which is also CE approved in Europe, now accounts for more than 8 patient years of life powering the Total Artificial Heart worldwide."
During Q1 2011, SynCardia enrolled 12 new hospitals to its certification program, including Texas Heart Institute, Cedars-Sinai Medical Center and Texas Children's Hospital. Currently, there are 37 SynCardia Certified Centers around the world including 15 in the U.S. There are an additional 32 hospitals currently completing the certification process, 14 U.S. and 18 international.
On April 13, SynCardia is hosting a Clinical Investigator Meeting for the 13.5 lb Freedom driver, the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. SynCardia expects triple the attendance from its previous Clinical Investigator Meeting, including surgeons from several international hospitals. The event will be held during the 31st annual meeting of the International Society for Heart & Lung Transplantation (ISHLT) in San Diego.
In its March 2011 issue, Fast Company magazine named SynCardia #20 in its annual list of the World's 50 Most Innovative Companies for "giving mobility to artificial heart recipients." Also in March, the longest running health and wellness series on public television, "Healthy Body, Healthy Mind" produced a 30-minute program about SynCardia's Total Artificial Heart.
CAUTION – The Freedom driver is an investigational device, limited by United States law to investigational use.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 175 patients, accounting for over 100 years of support.