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
AHA announces Quest for Quality Prize winner and finalist
Hartford HealthCare in Hartford, Conn., will receive the 2025 AHA Quest for Quality Prize as a result of their sweeping transformation over the past decade —…
Headline
AHA Trustee Insights examines leading board practices on quality and patient safety
A Q&A in the July edition of AHA Trustee Insights features leaders from Winchester Hospital in Massachusetts discussing the importance of board members…
Headline
AHA resource provides strategies, best practices on sepsis care from Ochsner Health
To help hospitals across the country improve sepsis care, the Centers for Disease Control and Prevention created the Hospital Sepsis Program Core Elements,…
Headline
Joint Commission streamlines accreditation process, removes over 700 requirements 
The Joint Commission June 30 announced a new, streamlined process that removes 714 requirements from its hospital accreditation program. The new program,…
Headline
AHA’s Pollack details significant progress hospitals have made improving patient safety
AHA President and CEO Rick Pollack explains how hospitals have made meaningful progress in patient safety and delivering high-quality care, in a column…
Headline
FDA doesn’t appeal court ruling invalidating lab-developed tests rule, effectively eliminating it
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-…