On March 4, SynCardia Systems, Inc., manufacturer of the SynCardia
temporary CardioWest™ Total Artificial Heart, announced that its new
Freedom™ driver system has received the CE Mark to power the Total
Artificial Heart in Europe.
“It will allow stable European Total Artificial Heart
patients to enjoy a quality lifestyle at home and in their communities
while they wait for a matching donor heart.”
“The new Freedom driver is the first wearable portable driver for
powering the Total Artificial Heart,” said Rodger Ford, president and
CEO of SynCardia. “It will allow stable European Total Artificial Heart
patients to enjoy a quality lifestyle at home and in their communities
while they wait for a matching donor heart.”
SynCardia hospital drivers support patients from Total Artificial Heart
implant until their condition stabilizes. Once stable, European patients
will be switched to the Freedom driver and discharged from the hospital
to wait for their matching donor heart at home.
The Freedom driver weighs 13.5 lbs including two onboard lithium ion
batteries and a power adaptor. It can be conveniently carried by the
patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is
60% lighter than SynCardia’s older CE approved “proof of concept”
portable driver, which weighs approximately 35 lbs and is transported in
a wheeled caddy.
The Freedom driver uses a “dark cockpit” design philosophy for simple
and easy operation. Similar to an airplane cockpit, the system only
flashes a light or sounds an alarm when something requires the user’s
attention.
To make maintenance easier for hospitals, the Freedom driver is serviced
by replacement via express delivery. No onsite repair or inventory of
parts is required by the hospital.
SynCardia has also submitted an application to the FDA to conduct an
Investigational Device Exemption (IDE) clinical study of the Freedom
driver in the U.S.
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