SynCardia Sends Letter Warning About Heart Driver System
SynCardia Systems alerted surgeons last week to possible safety risks involving its Total Artificial Heart Companion 2 driver system after receiving information of more frequent deaths among a patient subgroup using the device.
According to the Tucson, Ariz., devicemaker, 60 percent of patients requiring preimplant circulatory rescue interventions who used the C2 driver system died, compared with 17 percent of those who used an earlier model.
The FDA conducted its own analysis of data from patients implanted on or after July 9, 2012, and found a similar link between the C2 driver system and higher mortality in this subgroup. Patients not requiring preimplant intervention had comparable mortality rates with both drivers.
Despite the safety concerns, SynCardia says the C2 driver system might still be the best treatment option for some patients.
The TAH-t won FDA approval in 2004, initially with the firm’s Circulatory Support System console. The smaller, more mobile C2 driver system was approved in 2012. — Jason Scott