News | March 30, 2010

Investigational Study Examines Portable Artificial Heart Driver System

March 30, 2010 – The FDA granted an investigational device exemption (IDE) for a clinical study of the Freedom portable driver system to power SynCardia's Total Artificial Heart. The study is designed to demonstrate that stable Total Artificial Heart patients in the U.S. can manage their portable driver outside the hospital environment, including at home and in step-down facilities.

While the Total Artificial Heart has the one of the highest bridge to transplant rates of all approved mechanical circulatory support devices, the major drawback is it confines patients to the hospital while they await a transplant. This is because the only FDA-approved driver for powering the device is the 418-pound hospital driver nicknamed “Big Blue.” Patients who meet study criteria will have the option to be discharged from the hospital with the Freedom driver, with the goal of enabling them to resume normal activities. The portable driver weighs 13.5-pounds, which includes two onboard lithium-ion batteries and a power adaptor. It is carried by the patient in a backpack or shoulder bag.

“While waiting for a transplant, patients can stay in the hospital for several months and in some rare cases, more than a year,” said Dr. Stephen Clayson, associate surgical director of the Utah Artificial Heart Program at Intermountain Medical Center. “We are pleased to initiate the IDE clinical study and evaluate the use of the Freedom driver to power the Total Artificial Heart. If the IDE clinical study of the Freedom driver is successful, patients will be able to sleep in their own bed, spend time with their families and be more self-sufficient.”

The study is designed to demonstrate that the driver is a suitable pneumatic driver for stable artificial heart patients and can be used safely at home. The trial is expected to enroll 60 patients and will follow them until transplant, 90 days after discharge or death. Centers anticipated to participate in the study include University Medical Center at the University of Arizona, Intermountain Medical Center and Virginia Commonwealth University Medical Center.

The Freedom driver uses a “dark cockpit” design, meaning the driver only flashes a light and sounds an alarm when something requires the user’s attention. The Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

On March 1 the Freedom driver received CE approval for use in Europe.

For more information: www.syncardia.com

Related Content

Heavily calcified coronary arteries seen on a CT scan of the heart. Research at the New York Institute of Technology will create blood flow modeling to show the impact of calcium in arteries as part of a project to develop treatments to remove calcium.

Heavily calcified coronary arteries seen on a CT scan of the heart. Research at the New York Institute of Technology will create blood flow modeling to show the impact of calcium in arteries as part of a project to develop treatments to remove calcium. 

News | Cardiovascular Clinical Studies | January 27, 2021
January 27, 2021 — A New York Institute of Technology research te
Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di