Navigation Links
FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
Date:3/31/2015

TUCSON, Ariz., March 31, 2015 /PRNewswire/ -- SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart.

The FDA approval will allow SynCardia to launch the study with as many as 30 heart failure patients. Patients enrolled in this study will receive the 50cc SynCardia Total Artificial Heart as a bridge to a donor heart transplant. (Caution-In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)

Learn more about the SynCardia Total Artificial Heart

Pictured left 70cc and right 50cc SynCardia temporary Total Artificial Hearts. SynCardia Systems, Inc. has received FDA approval to launch an Investigational Device Exemption study into the effective use of the new 50cc SynCardia Heart.
Pictured left 70cc and right 50cc SynCardia temporary Total Artificial Hearts. SynCardia Systems, Inc. has received FDA approval to launch an...

"This study will allow smaller patients who can't fit the 70cc Total Artificial Heart to benefit from SynCardia's Total Artificial Heart technology," says Michael P. Garippa, President and CEO of SynCardia Systems, Inc. "Together, both device sizes are intended to make Total Artificial Hearts available to most women and men as well as many adolescents."

Under the study, the 50cc SynCardia Total Artificial Heart initially will be available for implantation in

  • 10 pediatric patients 10-18 years old
  • 10 adult patients 19-75 years old
  • 10 patients who would not otherwise qualify under the study criteria. This secondary arm is expected to further characterize the use of the 50cc SynCardia Heart.

All patients in the study must be eligible for donor heart transplant.

As part of the study and to better understand the patient populations that can benefit from the 50cc SynCardia Heart, images of the patients' chest cavities will undergo 3D modeling.

The SynCardia Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular heart failure in which the native heart's two ventricles can no longer pump enough blood for the patient to survive.

Study data through the first six months of patient use will be provided to the FDA as part of its review and approval process. Patients will be followed for up to two years to report on their experiences.

In Europe, both sizes of the SynCardia Total Artificial Heart have CE mark approvals for use as a bridge to donor heart transplant or as destination therapy, also known as permanent use. Use of the SynCardia Heart for destination therapy varies by country.

For additional information, please visit: http://www.syncardia.com/
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn
Share and Discover on Google+

About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,400 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom driver has been used by more than 200 patients, accounting for over 130 patient years of support.

Photo - http://photos.prnewswire.com/prnh/20150330/195470

 

 

 


'/>"/>
SOURCE SynCardia Systems, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGICS PANTHER SYSTEM
2. FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
3. FDA approves drug tested by Scottsdale Healthcare and TGen
4. FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologics Panther System
5. PMDA Approves Jarvik 2000 Heart in Japan
6. Cardinal Health Board of Directors Approves Quarterly Dividend, Authorizes Increase to Share Repurchase Program, Announces Board Leadership Changes
7. FDA Approves Pembrolizumab for Advanced Melanoma
8. FDA approves PleximmuneTM for personalized prediction of transplant rejection in children
9. FDA Approves VisionCares Telescope Implant for Macular Degeneration in Patients 65 Years and Older
10. Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
11. AbbVie to Present Data on Investigational Anti-Cancer Compounds at American Society of Clinical Oncology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):