A tracheal scaffold and bioreactor system manufactured by Holliston-based Harvard Bioscience were used in the first successful transplant of a regenerated trachea in the United States, the company announced.
The recipient of the implant, 2-year-old Hannah Genevieve Warren, is recovering at Children’s Hospital of Illinois, where the surgery was performed April 9, the company said. The surgery was also the world’s first successful pediatric regenerated trachea transplant using a synthetic scaffold.
The patient was born without a trachea and was only able to breathe through a tube inserted in her esophagus that connected to her lungs, the company said. No child born with the condition has ever lived beyond the age of 6. Hannah, who was born in South Korea, lived in the intensive care unit at a hospital in Seoul before she was transported to Illinois for the surgery.
The procedure was performed by a team led by Dr. Paolo Macchiarini of Karolinska University Hospital and Karolinska Institutet in Huddinge, Stockholm, and Drs. Mark J. Holterman and Richard Pearl, both of Children’s Hospital of Illinois. The surgery was approved by the FDA under an Investigational New Drug application made by Dr. Holterman, according to a statement from Harvard Bioscience.
