por John R. Fischer
, Senior Reporter | July 20, 2021
Surgeons at Duke University Hospital have successfully implanted a new generation artificial heart for the first time in a patient in North America.
Developed by CARMAT, the heart has been studied and approved for use in Europe and was implanted into a 39-year-old-man with heart failure at Duke as part of an FDA-approved trial.
“We are encouraged that our patient is doing so well after the procedure on Monday. As we evaluate this device, we are both excited and hopeful that patients who otherwise have few to no options could have a lifeline,” said Dr. Carmelo Milano, a transplant surgeon and the principal investigator of the device study at Duke, in a statement.
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The study will assess if the artificial heart is a viable option as a lifesaving step before transplant in 10 patients with end-stage biventricular heart failure. Duke is among only three transplant centers in the U.S. selected to join the study and implanted the first heart into Matthew Moore, of Shallotte, North Carolina.
The artificial heart is an implantable prosthetic that is made up of biological valves derived from bovine tissue and operates on an external power supply. It also auto-regulates itself and its biocompatibility leaves less of a need for coagulation and helps reduce the development of clots and chance for stroke. The device, however, has one challenge in that its size is large, but Duke researchers expect future versions to be reduced in size.
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.