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Managing Editor  | October 2017

American surgical team completes first 3-D printed sternum implant procedure


Anatomics, an innovative Australian medical device manufacturer, provided a surgical team at New York-Presbyterian/Weill Cornell Medical Center (New York City) with a custom 3-D printed sternum and partial ribcage implant made from titanium and porous polyethylene (PE).

 

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A U.S. patient has received a customized sternum and partial ribcage made from 3D printed titanium and combined with Anatomics ‘PoreStar’ technology. (CSIRO)

 

It was successfully implanted on Aug. 2, becoming the first such device to be implanted in the U.S. and only the second in the world.

 

According to a press release from Anatomics, the device was created based on high-resolution CT scans of the patient’s chest and reviewed by Dr. Jeffrey Port, the surgeon in New York. The implant was built at Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) 3-D Lab, Labb 22.

 

“The patient's custom sternum implant is the second in the world to also use Anatomics' PoreStar technology, a proprietary porous polyethylene material with bone-like architecture,” the release stated. “PoreStar is currently awaiting FDA marketing approval.”

 

The U.S. Food and Drug Administration (FDA) Expanded Access (Compassionate Use) Program allowed the customized 3-D implant to be used in the U.S. The program gives access to devices that the doctor believes will benefit a patient without prior FDA marketing approval.

 

This procedure was needed to revise an earlier reconstruction that was done in 2014 when the patient, Penelope Heller, had a malignant bone tumor removed from her sternum. After the cancer was removed, doctors created an implant using off-the-shelf Gore-Tex, which is a low-density porous polytetrafluoroethylene (PTFE), and bone cement.

 

Heller was cancer-free following the original surgery but was experiencing pain and issues with breathing. The family worked with the staff at New York-Presbyterian/Weill Cornell Medical Center to bring the Anatomics implant to the U.S.

 

"After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain," said Ms. 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."

 

Anatomics' Executive Chairman Paul D'Urso, MBBS (Hons) Ph.D. FRACS 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."

 

According to a report from CSIRO, the first sternum/ribcage implant was created for a cancer patient in Spain in 2015. The first implant that combined 3-D printed titanium and PE polymer was given to a British patient in 2016.

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