Success for first personalised, 3D-printed sternum implant procedure in USA

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3D-printed sternum
The surgery to implant a 3D-printed sternum was a US first

A US-first surgery to replace the sternum and part of the ribcage of a 20-year-old woman has been successfully completed by a team of surgeons at New York–Presbyterian Weill Cornell Medical Center, led by professor of clinical cardiothoracic surgery and attending cardiothoracic surgeon Jeffery L Port. The surgery, using a 3D-printed implant, is expected to pave the way for similar procedures in spine surgery.

Performed in August, the surgery was completed using a custom 3D-printed titanium and porous polyethylene sternum implant manufactured by Australian company Anatomics. The surgery, a first in the USA, was only the second time a 3D-printed sternum and ribcage has been implanted worldwide.

To access the implant, a request was made via the US FDA’s Expanded Access (Compassionate Use) program, which provides a way for patients to access devices that have not yet received medical clearance in the US. To be approved for one-off use, the treating physician must believe that the device will provide a strong benefit to their patient.

The patient, Penelope Heller, first underwent surgery in 2014 to remove a malignant bone tumour as a result of chondrosarcoma, a rare cancer that affecting the bones and joints that is resistant to both chemotherapy and radiotherapy. In that surgery, the tumour was removed and the patient received a Gore-tex (low-density porus polytetrafluoroethylene; PTFE) and bone cement (methyl methacrylate; MMC) implant.

While in the years following the surgery the cancer did not reappear, Heller continued to experience pain and breathing issues. Through her own research, she learned about the world-first surgery, carried out in Spain in 2015 by José Aranda and colleagues at Salamanca University Hospital using an implant also created 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 the FDA’s Expanded Access program.

“After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain,” said Heller. “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.”

Additive manufacturing in spine surgery

Additive manufacturing is an area of growing interest in medical devices, particularly in innovative spine devices, with several 3D-printed devices now on the market for spine fusion surgery and other procedures.

“The capacity to design an implant that fits perfectly for a given situation is gold,” said Ralph Mobbs, neurosurgeon at Prince of Wales Hospital, Sydney Australia, speaking to Spinal News International earlier this year.

In April this year, DePuy Synthes acquired additive manufacturing technology for creating bioresorbable implants for treating bone defects. Earlier this month, a white paper from Medicrea revealed a significant decrease in rod fractures with the implant of patient-specific rods created by additive manufacturing.

The 3D-printed sternum waiting to be implanted
The 3D-printed sternum waiting to be implanted

The sternum implant for Heller was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers to be translated into a 3D reconstruction for surgeons to review, which was then created using additive printing methods. The implant was printed at Lab 22, a 3D printing laboratory at Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO). CSIRO hosts an AU$1.3 million (£776,000) Arcam 3D electron beam metal printer that melts titanium powder at 1,650 degrees Celsius to, layer-by-layer, create a complete device.

“Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology,” said Paul D’Urso, executive chairman of Anatomics. “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.”

The patient’s 3D-printed custom sternum implant, like the one used in the world-first procedure in Spain, utilises Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA approval for the United States.

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