The Title of the Video Would Go Here

SynCardia Video Center: News


Video Length - 2:30

FDA Could Approve
New Heart Transplant Technology

CBS Houston

May 15, 2012 - The FDA could fully approve a heart device for use without a transplant in weeks.

SynCardia’s Total Artificial Heart is a pump implanted in place of the heart, powered by a backpack-sized driver so the patient is able to leave the hospital and lead a nearly normal life.

“I would not be here today without the device,” said Shawn Galloway, a Total Artificial Heart recipient. “People die every single day because they don’t get an organ in time.”

News Update:
On March 2, the U.S. Food and Drug Administration (FDA) approved a Humanitarian Use Device (HUD) designation for the Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant. The next step is for SynCardia to submit a Humanitarian Device Exemption (HDE) to the FDA. Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not transplant-eligible to receive the Total Artificial Heart on a permanent basis.

*The Freedom® portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. CAUTION – The Freedom driver is an investigational device, limited by United States law to investigational use.

 
  1. News
  2. Patient Stories
  3. Educational
  4. For Medical Professionals
alt
Congenital Heart Disease & the SynCardia Total Artificial Heart

FEATURED VIDEO:
Congenital Heart Disease & the SynCardia Total Artificial Heart

Iki Adachi, MD
Pediatric congenital heart surgeon, Texas Children’s Hospital, and assistant professor of surgery, division of congenital heart surgery, Baylor College of Medicine

David L.S. Morales, MD
Chief of cardiothoracic surgery at the Heart Institute, Cincinnati Children’s Hospital Medical Center

 

alt 00aintermac

INTERMACS 1 Patients & Biventricular Failure

Francisco Arabia, MD
Surgical Director of Mechanical Circulatory Support

alt Cardiogenic Shock & the SynCardia Total Artificial Heart

Cardiogenic Shock &
the SynCardia Total
Artificial Heart

Francisco Arabia, MD
Surgical Director of Mechanical Circulatory Support

 

00aimpact

Impact of Right Ventricular Failure on the Vital Organs

Michael L. Hess, MD
Professor of Medicine, Division of Cardiology, Advanced Heart Failure Program

 

alt 00agraft

Transplant Graft Failure & the SynCardia Total Artificial Heart

Jack Copeland, MD
Professor of Surgery

alt 00akidney

Q&A: End Organ Recovery

David L.S. Morales, MD
Chief, Pediatric Cardiothoracic Surgery and Executive Co-Director, The Heart Institute

Michael L. Hess, MD
Professor of Medicine, Division of Cardiology, Advanced Heart Failure Program

 

00arightfailure

How Do You Measure RV Dysfunction/Failure?

Michael L. Hess, MD
Professor of Medicine, Division of Cardiology, Advanced Heart Failure Program

alt 00acongential

Congenital Heart Failure and the TAH with Q&A

David L.S. Morales, MD
Chief, Pediatric Cardiothoracic Surgery and Executive Co-Director, The Heart Institute

alt 00arenalfailure

Q&A Renal Failure

Francisco Arabia, MD
Surgical Director of Mechanical Circulatory Support

Jack Copeland, MD
Professor of Surgery

00alvadvstah

LVAD vs. TAH-t
Don't Take the Risk

Michael L. Hess, MD
Professor of Medicine, Division of Cardiology, Advanced Heart Failure Program

       

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

FREE News Sign-Up

3538727_sBe Among the First to
Receive SynCardia News

... right in your email box