Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke
[Posted 08/17/2018]
AUDIENCE: Transplantation, Surgery, Cardiology
ISSUE: FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
BACKGROUND: Syncardia’s TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The TAH-t replaces a patient's native ventricles and valves to completely take over pumping of blood to both the pulmonary and systemic circulation. The TAH-t is used with an external pneumatic driver which activates the implanted device. The C2 Driver System is one of the available external pneumatic drivers.
The TAH-t was initially approved for use by the FDA in 2004, with the CSS Console as its initial driver system. The FDA approved the smaller C2 Driver System in 2012. Both driver systems were approved for use only in the hospital setting. In addition to the in-hospital driver systems, the FDA approved the portable Freedom Driver System in 2014. The Freedom Driver System can be used outside of the hospital, allowing some TAH-t patients to return home while on the device.
RECOMMENDATION: The FDA has the following recommendations for health care providers:
AUDIENCE: Transplantation, Surgery, Cardiology
ISSUE: FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
BACKGROUND: Syncardia’s TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The TAH-t replaces a patient's native ventricles and valves to completely take over pumping of blood to both the pulmonary and systemic circulation. The TAH-t is used with an external pneumatic driver which activates the implanted device. The C2 Driver System is one of the available external pneumatic drivers.
The TAH-t was initially approved for use by the FDA in 2004, with the CSS Console as its initial driver system. The FDA approved the smaller C2 Driver System in 2012. Both driver systems were approved for use only in the hospital setting. In addition to the in-hospital driver systems, the FDA approved the portable Freedom Driver System in 2014. The Freedom Driver System can be used outside of the hospital, allowing some TAH-t patients to return home while on the device.
RECOMMENDATION: The FDA has the following recommendations for health care providers:
- Carefully consider these mortality and stroke results from the TAH-t post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients.
- Return all devices associated with, or suspected to be associated with, any adverse events to the manufacturer for evaluation to help them and the FDA better understand the issue.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/17/2018 - Letter to Health Care Providers- FDA]
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