Postapproval results for SynCardia Systems’ Companion 2 (C2) driver system for temporary total artificial hearts (TAH-t) have shown higher mortality and stroke rates than were seen with the previous system, the circulatory support system. As a result, the Food and Drug Administration has issued a safety alert cautioning them to weigh the risks and benefits carefully. The alert, issued on August 17, is based on a postapproval study conducted by SynCardia Systems.
Furthermore, patients and health care professionals are encouraged to report any adverse events using the FDA’s Medwatch reporting form, as well as return any devices associated with adverse events to the SynCardia Systems to help them and the FDA better understand the issue.
The C2 driver system is an external pneumatic system that activates an implanted TAH-t in eligible heart failure patients who have severe biventricular failure and are waiting for transplant. It is smaller than its predecessor, but per the device’s approved use, patients must still remain in the hospital while on the device. Since its approval in 2012, the Freedom driver system was approved in 2014, which allows patients to return home.
The full safety alert can be found on the FDA website.