On August 2, 2017, an American surgical team replaced the sternum and partial ribcage of a 20-year-old woman using a custom 3D-printed composite titanium/porous polyethylene (PE) implant. It is the first time this technology has been used in the United States and only the second time in the world that a 3D-printed composite sternum and ribcage has been implanted.
The device was designed and created by Anatomics, an Australian company based in St. Kilda that specializes in the manufacture of patient-specific implants. Because Anatomics’ 3D-printed implants do not have FDA approval, the company applied the agency’s Expanded Access (Compassionate Use) program, which provides a pathway for patients and their treating physicians to use devices that have not been cleared by FDA but that may provide a benefit.
The surgical team, led by Jeffrey L. Port, MD, attending cardio-thoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardio-thoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor.
In the original procedure, the cancer was successfully removed and the surgeon created an implant using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and bone cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve over time. Online research led the patient to find a similar surgery performed in Spain using a custom implant developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under FDA's Expanded Access program.
High-resolution CT scans of the patient's chest were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient's sternum and ribcage was created and a build code was sent to a 3D-printing lab in Australia.
The custom sternum implant is the second in the world to use Anatomics' PoreStar technology, a proprietary porous PE material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.
"After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain," said the patient. "With a long, active life ahead of me, I wanted to participate in activities that I love fully and without pain. Electing to have this procedure was a big decision, and I'm coming forward to empower other people in the same position."
Anatomics' Executive Chairman Paul D'Urso, PhD, said, "Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology. The patient's story is one of many, but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at NewYork-Presbyterian/Weill Cornell, Anatomics, and the FDA came together to make this story a reality. It was a group effort that began with the patient's pursuit of information."