Discharge Drivers (U.S.)

Freedom for Life

SynCardia has received conditional approval from the FDA to conduct an IDE clinical study of the small and wearable Freedom™ driver system in the U.S. The SynCardia Freedom driver system IDE study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.

Anticipated Benefits of Discharge

When the Freedom driver becomes available through the IDE clinical study, SynCardia anticipates that discharging stable patients may eliminate in-hospital costs for this portion of their care and allow U.S. hospitals to be reimbursed for both major medical procedures: 

1. Total Artificial Heart implant
2. Subsequent heart transplant

Without discharge, hospitals only receive reimbursement for the heart transplant.

*CAUTION – The Freedom™ driver system is an investigational device, limited by United States law to investigational use.

The Freedom™ driver system* and the 70cc SynCardia Total Artificial Heart

“If I'd had a portable driver, I could've done almost anything. I would've been able to do things with my kids and do the everyday stuff that I missed while I was in the hospital. Everything from watching my son’s basketball games and my daughter’s cheerleading competitions, to taking them to the park, going grocery shopping, playing games with them at night and getting up in the morning to make them lunch for school.”

 
Jim Hennigan
Levittown, Pennsylvania
Implant date: July 2, 2008
Transplant date: May 8, 2009
Hospital of the University of Pennsylvania