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

Webinar Recordings
Member
Learn how a Patient Risk Assessment Profile allowed nurses to proactively assess patient risk to guide staffing decisions and nurse-patient assignment.…
Webinar Recordings
Member
Tuesday, August 6, 2019
Letter
Public
AHA encourages Congressional leaders to pass the Pandemic and All-Hazards Preparedness…
Issue Brief
How are value and health equity connected?
Letter
Public
Download the letter (PDF) below Re: CMS—3346—P, Medicare
Case Studies
In 2001, a Samaritan Health Services (SHS) physician, Dr. Richard Wopat, recognized the need to improve birth outcomes of high-risk pregnant women in the…