SynCardia: SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver

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 [...]The post SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver appeared first on MassDevice.