Developers of a cutting-edge lab-grown blood vessel designed to save life and limb in war zones and other emergency scenarios appear to be promoting its use in surgeries far beyond the product’s approved scope. The “off-label” use of these bioengineered tissues comes despite indications of questionable efficacy and potentially catastrophic ruptures.
The biotechnology firm, Humacyte, has developed an artificial blood vessel, called Symvess, that was approved by federal regulators for use in adults with trauma to their arms or legs who urgently need new arteries “to avoid imminent limb loss.”
But at a premier vascular surgery conference this November, Humacyte promoted research presentations on alternative uses of its vessels from a clinical trial — part of a growing trend of “off-label” uses of medical devices.
One of those presentations focused on off-label use of the vessels in patients’ torsos, which, according to data omitted from a prominent medical article on the product, were unsuccessful in four out of five procedures. In two of those cases, the patient died. The other presentation detailed the use of tissues in surgeries for individuals with kidney failure, procedures that the company previously discouraged the surgeon involved from undertaking.
Humacyte confirmed that both presenters have received compensation from the company in the past, though they were not paid in connection with their conference presentations.
“I find it ethically problematic that several speakers failed to declare from the beginning of their talks that they would be describing usage of the Humacyte graft that was not FDA approved,” said Robert Lee, a vascular surgeon and former medical officer at the Food and Drug Administration (FDA), which attended the November presentations and voiced concerns about the matter during the talks. In September 2024, Lee left the federal agency in protest following a ten-year term, after he’d repeatedly warned that…
Auteur: Helen Santoro
