From the April 2022 issue of HealthCare Business News magazine

If approved by the FDA, it could be used for patients whose hearts require assistance to pump blood through both chambers. Many currently rely on left-ventricular assist devices, which support just one chamber. In addition, it could be used, as in the case with Moore, for patients whose condition is too risky for a transplant.

“Because of the shortages of donor hearts, many patients die while waiting for a heart transplant,” said Dr. Jacob Schroder, a transplant surgeon who led the implant procedure. “We are hopeful for new options to help these patients, many like Mr. Moore, who has a devastating disease and cannot otherwise be considered for a transplant.”


While Moore will eventually receive a permanent transplant when he is judged able to, the researchers expect that patients could live for years with this device.

St. Jude Medical to pay $27 million over allegations around faulty cardiac implants
It was announced in July that St. Jude Medical will pay $27 million to settle false claims allegations that it knowingly sold thousands of defective heart implants.

The U.S. Justice Department has accused the company of failing to disclose serious adverse health events, including one death, related to the premature depletion of the battery in certain models of implantable defibrillators.

“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents. We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Acting Assistant Attorney General Brian Boynton of the Justice Department’s civil division, said in a statement.

Abbott acquired St. Jude in January 2017. Kate Dyer, of Abbott's public affairs, said in a statement that “this relates to a matter that took place prior to Abbott's acquisition of St. Jude Medical.”

The department said in its case that the devices were sold to providers and then implanted between November 2014 and October 2016 into patients insured by federal healthcare programs.

It claims that St. Jude Medical knew by 2013 that lithium clusters were forming on and causing the batteries of these devices to short and suffer premature power drainage. This included certain models of its Fortify, Fortify Assura, Quadra and Unify devices.

The company in late 2014 submitted a request to approve a change to prevent lithium clusters from draining the battery and told the FDA that “no serious injury, permanent harm or deaths have been reported associated with this” issue. The Justice Department says this was a lie and that St. Jude Medical knew of two reported serious injuries and one death associated with premature battery depletion (PBD) induced by the lithium clusters, but continued to distribute the devices manufactured without the new design.

April 2022 Magazine

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