The FDA sent a letter to transplant surgeons and cardiologists on Oct. 26 with additional results regarding issues with SynCardia Systems, Inc.’s temporary total artificial heart companion 2 driver system (TAH-t C2 Driver System). The system serves as a bridge to a heart transplant for some heart failure patients.
The agency also mentioned recent problems with the company’s Freedom driver system.
In June 2015, the FDA alerted healthcare professionals of preliminary data from a post-approval study that found patients who required pre-implant circulatory rescue interventions had higher mortality rates if they received the TAH-t C2 Driver System than if they received the Circulatory Support System (CSS) Console. The mortality rates were similar for patients who did not require pre-implant circulatory rescue interventions.
Updated results from that trial showed that the mortality rate within three months was 39 percent in the C2 Driver System group and 25 percent in the CSS Console group among patients who required pre-implant circulatory rescue interventions. For patients who did not require pre-implant circulatory rescue interventions, the mortality rate within three months was 27 percent and 21 percent, respectively.
In addition, the neurological adverse event rate in the first three months was 31 percent in the C2 Driver System group and 16 percent in the CSS Console group. The neurological adverse events included transient ischemic attacks, confusion, ischemic/embolic stroke, hemorrhagic stroke, strokes from other causes, seizures, encephalopathy and other events.
The FDA also acknowledged recent reports of serious, life-threatening device malfunctions involving the Freedom driver system. The FDA recalled the Freedom driver system in August 2015, but the agency said the recent reports were likely unrelated to the previous issues.
Earlier this month, Kaiser Health News reported that officials at Cedars-Sinai Medical Center in Los Angeles believe a 57-year-old man who had an artificial heart implanted at their hospital may have died due to failure of the Freedom driver. Two other patients who received the Freedom driver at Cedars-Sinai were subsequently readmitted to the hospital.
“The FDA is working with SynCardia and clinicians to fully assess reports of malfunction involving the Freedom Driver System,” FDA executive William Maisel, MD, MPH, wrote in the letter. “In light of these recent reports, the FDA advises that clinicians review the operator manual's specific precautions regarding Freedom Driver System use outside of a hospital environment, and carefully consider individual patient circumstances when evaluating the Freedom Driver System as a treatment option.”
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.