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FDA recognizes increased risk for stroke, mortality with SynCardia driver system
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The FDA has determined that a device by SynCardia Systems for patients with HF and severe biventricular failure before a heart transplant increases the rate for mortality and stroke when supported with a newer driver system.
Final results from a post-approval study were reviewed for the device (temporary Total Artificial Heart) and the newer driver system (Companion 2 [C2] Driver System), which was compared with patients who had a previous-generation driver (Circulatory Support System console), according to a MedWatch report from the FDA.
The device replaces native ventricles and valves to aid in pumping blood to the pulmonary and systemic circulation, and the external pneumatic driver activates the implanted device.
The FDA approved the device with the previous-generation driver in 2004, and the newer driver was approved in 2012, according to the report. Both systems were only approved for use in the hospital setting. Another driver (Freedom Driver System) was approved in 2014 for use outside of the hospital.
The FDA recommends that health care providers consider the increased risk for mortality and stroke when making treatment decisions and to discuss the benefits and risk with patients. Devices that have been associated with adverse events should be returned to the manufacturer for evaluation, according to the report. Patients and health care providers should also report side effects or adverse events related to the products.
On Aug. 24, 2018 — a few days after the FDA issued the report — SynCardia sent a response letter to clinical partners to clarify what the FDA detailed in its report.
“We stand behind the C2 Driver as the hospital driver used to support SynCardia [temporary total artificial heart] patients,” Michael Garippa, president and CEO of SynCardia Systems, wrote in the letter. “As required by FDA, a summary of the results of phase I of our [post-approval study] will be added to product labeling, and surveillance of our products will continue in phase II of our [post-approval study].”
Disclosure: Garippa is an employee of SynCardia Systems.