SynCardia Systems sent a letter to surgeons yesterday warning them about issues with a component of its artificial heart in patients who received pre-implant circulatory rescue interventions.
The letter concerns Syncardia’s Total Artificial Heart Companion 2 Driver system. SynCardia won FDA approval for the C2 system in 2012 as a smaller replacement for the CSS console, which won FDA approval with the company’s artificial heart in 2004.
The FDA said that “interim analyses suggest that patients who required pre-implant circulatory rescue interventions (such as intra-aortic balloon pump or extracorporeal membrane oxygenation) had a higher mortality rate when using the C2 Driver system as compared to the Circulatory Support System console.”
The warning notes that in a postapproval study assessing postmarket performance, a 60% mortality rate was recorded in 38 patients who underwent pre-implant circulatory rescue interventions using the C2 Driver System, compared to 17% in CSS Console patients. There was no significant difference in patients who did not receive pre-implant circulatory rescue interventions.
The FDA said it conducted its own analysis of data from patients implanted with the C2 Driver system on or after July 9, 2012 and found a higher mortality rate for the subgroup of patients who received pre-implant circulatory rescue interventions.
The FDA will work with SynCardia and the Interagency Registry for Mechanically Assisted Circuulatory Support to help uncover the cause for the increased mortality rates in the specific subgroup, the federal watchdog said.
In March, Syncardia won FDA investigational device exemption approval for a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.