In 2004, the Food and Drug Administration (FDA) approved the SynCardia temporary CardioWest™ Total Artificial Heart as a bridge to transplant for patients dying from end-stage biventricular failure. During the pivotal clinical study, 79 percent of near-death patients survived to transplant. This is the highest bridge to transplant rate of any approved heart device. Currently, SynCardia’s Total Artificial Heart is powered by a 418-lb pneumatic driver nicknamed “Big Blue.”
According to one patient’s story detailed on the SynCardia website, Jim Hennigan “looked and felt too healthy to be in the hospital” while living with the Total Artificial Heart and the Big Blue hospital driver.
Now, SynCardia is working with Bimba Manufacturing and Smart Products to develop the new Freedom™ driver system, which is designed to allow stable Total Artificial Heart patients to leave the hospital to wait at home for a matching donor heart.
“The Freedom driver is designed to be the world’s smallest pneumatic driver for powering the Total Artificial Heart,” says Bob Guillemette, Chief Engineer at Bimba Manufacturing.
“The pump design by Bimba is a great innovation, but after initial testing, we realized the need for a smaller valve with side seal capability in order to make it perform with ease and efficiency,” said Cathy Jernigan, Director of Sales & Marketing for Smart Products. “We were excited that Bimba’s need drove us to create a new side seal valve to precisely fit this driver.”
The Freedom driver utilizes a proprietary pump that sends pulses of low pressure air to inflate the two diaphragms in the Total Artificial Heart, which pump the blood. This produces high cardiac output through both the left and right ventricles of the Total Artificial Heart. The Freedom driver is designed to run on a household current, a car battery, and its own rechargeable batteries.
“The Freedom driver utilizes a ‘black cockpit design,’” said Don Isaacs, Vice President of Communications for SynCardia. “The patient is only alerted when something requires their attention: a battery alert sounds when one of two removable batteries drops below 35 percent charge, and a driver alert indicates when the patient should switch to their back-up driver.”