FDA Approval Gives Mobility to Total Artificial Heart Patients

Clinically stable patients waiting for heart transplants do not have to be tethered to large clinical equipment. They can live at home, socialize, eat at restaurants, go boating, exercise--even box, according to SynCardia, maker of the Freedom portable driver. The FDA on June 26 approved use of the driver with the SynCardia's temporary artificial hearts, the Arizona company announced yesterday.Patients can carry the 13.5-lb. driver in a backpack, shoulder bag, walker, or pull it in a rolling caddy. It powers SynCardia's Total Artificial Heart with precisely calibrated pulses of air and a small amount of vacuum so the diaphragm is properly positioned to accept the next filling of blood into each artificial ventricle, according to a company statement."These patients can be discharged and live in their homes and communities while they wait for their matching donor hearts," Michael Garippa, SynCardia's CEO and president, said in a statement. "We anticipate that this will save patients, hospitals and insurance companies thousands of dollars through eliminating most in-hospital costs for this portion of patient care."SynCadia released a promotional video showing two recipients of its total artificial heart patients who happen to box as a hobby. One of the patients was shown without the Freedom driver while the other was shown using it. With the FDA approval of the Freedom driver, stable patients who need IV therapy or outpatient dialysis will be able to be take care of those conditions on an outpatient basis.

To obtain PMA approval for the driver, SynCardia provided the Freedom device to 96 SynCardia artificial heart patients through 22 SynCardia-certified centers in the U.S. to gather data for a clinical study. The company provided drivers to an additional 10 patients under compassionate-use exemptions at nine other centers.The combined artificial heart and driver allowed 75% of those patients to be discharged from the hospital, while 86 percent either received heart transplants or were still using the driver as of June 30.The Freedom driver runs on lithium-ion batteries that users can recharge with a standard electrical outlet or a car charger, which works in many boats. It represents an evolution of portable drivers that the company has had approved since the 1980s. The 418-lb. "Big Blue" driver powers the temporary artificial heart for inpatients but restricts their mobility. The company's Companion 2 (C2) Driver system, improves patient mobility within the hospital until their conditions stabilize. The C2 won a silver Medical Design Excellence Award in 2013.

Once stable, eligible patients can be switched to the Freedom portable driver and leave the hospital while waiting for a donor heart. European regulators approved the Freedom driver in 2010, followed by Canadian regulators the following year. One hundred of SynCardia's artificial hearts were implanted as of July 2013, three months earlier than the company had projected.Last year, SynCardia Systems was a silver winner in the 2013 Medical Design Excellence Awards (MDEA).

Nancy Crotti is a contributor to Qmed and MPMN.

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