News | March 11, 2011

Texas Children's First to Begin Certification Process for Artificial Heart

March 11, 2011 – Texas Children's has become the world's first pediatric hospital to complete the first phase of certification to implant the SynCardia temporary Total Artificial Heart. The hospital intends to use the device as a bridge to transplant for their patients who received a heart transplant as children and now require mechanical support as a bridge to their second transplant.

The 15-member training team, which included cardiologists, critical care intensivists, anesthesiologists, nursing specialists and hemotologists, was led by David L.S. Morales, M.D., pediatric cardiovascular surgeon and director of mechanical circulation support at Texas Children's Hospital. This first-phase of certification prepares the team for future implantation of the device into patients who meet specific body-size qualifications.

Similar to a heart transplant, the Total Artificial Heart replaces both failing ventricles and the four cardiac valves. Once implanted, it pumps up to 9.5 liters per minute through both ventricles to provide increased blood flow to vital organs such as the brain, kidneys and liver. Unlike a donor heart, the device is instantly available before the patient's organs begin to fail and doesn't require expensive, anti-rejection medication, which can cause subsequent complications.

"Over the past few years as a transplant surgeon at Texas Children's Hospital, I have witnessed several patients who needed a second transplantation, but died before a donor heart became available," said Morales. "Those patients would have been excellent candidates for an immediately-available heart. The Total Artificial Heart is the only device that allows us to remove the failing donor heart completely and bridge patients to a second transplant without immunosuppressive therapy."

Of the more than 20 patients currently listed for a heart transplant at Texas Children's, more than 20 percent are waiting for their second donor heart. Since its inception in 1984, Texas Children's heart transplantation program has grown into one of the largest and most successful of its kind in the nation, having transplanted 248 pediatric patients.

For more information: www.syncardia.com, www.texaschildrens.org

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...