On 25 July, SynCardia Systems announced that 100 SynCardia temporary Total Artificial Hearts have been implanted by SynCardia certified centres in 2013. A company release said that this milestone was achieved three months earlier than in 2012, when the 100 implant was performed on 16 October.
“2012 was a record-breaking year for SynCardia with 125 implants of the Total Artificial Heart at 54 SynCardia certified centres,” said Michael Garippa, SynCardia CEO and president. “Reaching 100 implants three months earlier than we did last year is a testament to our long-term growth trajectory, which will be close to tripling since 2009. We expect this growth to continue as more hospitals adopt the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure.”
The 100th implant of the Total Artificial Heart was performed by Virginia Commonwealth University (VCU) Medical Center in Richmond, USA.
“From January 2012 through the first seven months of 2013, there have been 230 implants of the Total Artificial Heart,” said Garippa. “This is nearly double the number of implants performed during the same 19-month period from 2010 to 2011, in which 120 implants were performed.”
SynCardia is currently awaiting a response from the FDA regarding its premarket approval supplement for the Freedom portable driver, the world’s first wearable power supply for the Total Artificial Heart. To date, 140 patients have been supported by the Freedom portable driver worldwide, accounting for more than 68 patient years of support. Of these patients, 89 were discharged from the hospital to wait for a matching donor heart at home and in their communities.
The Freedom portable driver is CE mark approved for use in Europe and undergoing an FDA-approved investigational device exemption (IDE) clinical study in the USA.