News | July 19, 2011

First Use of Freedom Portable Driver to Power Artificial Heart Published

July 19, 2011 — An article published in the July issue of the Journal of Heart and Lung Transplantation reports the first use of the Freedom portable driver with a Total Artificial Heart (TAH-t) patient. The TAH-t is manufactured by SynCardia Systems Inc.

“TAH-t use has been limited by the large operating console for the driver system that requires patients to remain hospitalized until transplantation,” wrote the article’s authors. “The Freedom driver allows clinically stable patients to await a donor heart as an outpatient.”

The patient, 41, was implanted with the TAH-t on Sept. 3, 2008 after his body rejected the donor heart he'd received at age 30. For more than 600 days, he was confined to the hospital by the 418-lb "Big Blue," the only U.S. Food and Drug Administration (FDA)-approved driver for powering the TAH-t. Due to the previous transplant, the patient’s body produced antibodies that made it challenging for him to receive a matching donor heart.

In March 2010, SynCardia received approval from the FDA to conduct an investigational device exemption (IDE) clinical study of the Freedom driver, the first U.S. portable driver designed to power the TAH-t both inside and outside the hospital. On May 3, 2010, this patient was discharged from the hospital to wait for a matching donor heart at home with his wife and children. He was supported by the Freedom driver for a total of 253 days before receiving a dual heart and kidney transplant on Jan. 15, 2011.

“The success of our first patient to be discharged home and then undergo transplantation is encouraging,” concluded the article’s authors. “Out-of-hospital management of the patient with a TAH-t appears feasible, and consideration for use of this device for longer-term applications may be held in the future.”

To date, the hospital has transferred six TAH-t patients to the Freedom portable driver while awaiting heart transplantation. The driver is also CE approved for use in Europe.

For more information: www.syncardia.com

Related Content

FDA Class I Recall Issued for Medtronic HeartWare HVAD Pump
News | Ventricular Assist Devices (VAD) | May 29, 2020
May 29, 2020 — Medtronic is recalling its HeartWare HVAD...
Abiomed Receives FDA PMA Approval for Impella 5.5 With SmartAssist
Technology | Ventricular Assist Devices (VAD) | September 27, 2019
Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre...
CorWave Presents First Successful In Vivo 60-day Study of Neptune LVAD
News | Ventricular Assist Devices (VAD) | September 12, 2019
CorWave announced successful completion of its first 60-day preclinical study to evaluate its Neptune left ventricular...
Experts Caution Against Catch-all Assumptions About LVADs and Mitral Regurgitation

Paul Tang, M.D., Ph.D., a cardiac surgeon at Michigan Medicine’s Frankel Cardiovascular Center in the OR. Image courtesy of Michigan Medicine.

News | Ventricular Assist Devices (VAD) | August 20, 2019
Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant...
FDA Confirms Impella RP is Safe and Effective
News | Ventricular Assist Devices (VAD) | June 12, 2019
 In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella...
Impella SmartAssist Platform Launches at SCAI
News | Ventricular Assist Devices (VAD) | May 22, 2019
Abiomed announced that the Impella CP with SmartAssist will be commercially available beginning at the 2019 Society for...
FDA Approves Impella 5.0 and Impella LD Extended Duration of Use
Technology | Ventricular Assist Devices (VAD) | May 14, 2019
The U.S. Food and Drug Administration (FDA) has approved the expansion of Abiomed’s Impella 5.0 and Impella LD...
FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
News | Ventricular Assist Devices (VAD) | May 02, 2019
Abiomed announced that, on April 26, the U.S. Food and Drug Administration (FDA) approved initiation of the ST-...
Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...