SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.
In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.
SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebrovascular accidents.
“None of the primary causes of death in the C2 Cohort was the result of a device malfunction. The Device Malfunction Adverse Event (AE) analysis revealed that the reliability of the C2 Driver is consistent with the reliability of the CSS Console as demonstrated by non-statistically significant rates of occurrence per 100 patient months of Device Malfunction AEs at three months (CSS: 1.8 vs. C2: 3.8) and six months (CSS: 1.8 vs. C2: 3.3) post-implant,” the company wrote in its response letter.
SynCardia said that data from the post-approval study also showed that most cerebrovascular accidents occurred within the first three months of TAH support, which the company believes “is due to patient pre-implant condition” and that patient duration on the C2 Driver does not result in a higher rate of adverse events.
The company said that it performed an in-depth multivariable logistic regression analysis under the post-approval study looking to identify pre-implant risk factors associated with mortality or CVAs compared to 70cc TAH-t patients initially supported by the C2 Driver, and found that neither had a statistically significant impact on mortality or CVAs.
“The C2 Driver System is pulsatile, pneumatic and operates in the same manner as the CSS Console. We stand behind the C2 Driver as the hospital driver used to support SynCardia TAH-t patients. As required by FDA, a summary of the results of Phase I of our PAS will be added to product labeling, and surveillance of our products will continue in Phase II of our PAS. We look forward to collaborating with FDA on study design improvements for Phase II, during which we will scrutinize patient pre-implant condition in more detail. Phase II will also include the subset of patients who transfer to Freedom Driver support,” Syncardia said in a press release.