FDA issues safety alert on temporary artificial heart

Aug 20, 2018 - 01:54 PM
FDA-warning

The Food and Drug Administration Aug. 17 issued a safety alert after reviewing the final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System. SynCardia’s TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The study results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver – the Circulatory Support System Console – FDA said. “We recommend that you carefully consider these mortality and stroke results from the TAH-t post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients,” FDA said in a letter to providers. FDA also encourages providers to report any adverse events or suspected adverse events experienced with the SynCardia TAH-t and Driver Systems.

Related News Articles

Headline
Study: Two-dose antibiotic may be as effective as IV therapy for serious staph infections 
A study published by JAMA Aug. 13 found that a two-dose antibiotic treatment could be just as effective as traditional long-term IV therapy for treating…
Headline
CDC says COVID-19 cases growing or likely growing in 45 states 
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Perspective
Hospitals Work to Improve Patient Safety Every Day
Public
Hospitals and health systems across the country vary in size, as well as the types of services and specialties they offer. They also offer many different…
Headline
AHA launches new hub on reducing disparities in health outcomes 
The AHA Aug. 7 launched a new webpage, Reducing Disparities in Health Outcomes, featuring new and familiar resources for members and their communities. As part…
Headline
AHA podcast: Workforce Culture is the Key to Patient Outcomes
Nell Buhlman, chief administrative officer and head of strategy at Press Ganey, and Chris DeRienzo, M.D., AHA chief physician executive, explore the data-…
Headline
HHS announces pilot program to combat hepatitis C in homeless communities
The Department of Health and Human Services July 28 announced the creation of a $100 million pilot program to prevent, test for, treat and cure hepatitis C for…