writes copy 03 Nov 2017

3D Printing and Personalized Healthcare is Here to Stay Anatomics Shares Deeper Look at USFirst 3D Printed Implant Regulatory Environment

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Anatomics’ 2015 3D printed titanium implant

When in 2015 a 3D printed titanium sternum implant provided custom care to a Spanish cancer patient, it wasn’t just an impressive medical achievement for the books; the patient-specific implant and the technology used to create it became a source of inspiration to others afflicted by similar conditions. Penelope Heller, diagnosed in 2014 with chondrosarcoma, was inspired by the original 3D printed sternum implant when her own off-the-shelf implant didn’t let the 20-year-old live the active life she wanted to following her recovery. We recently learned her story, as Australia-based Anatomics shared her journey in having her own customized implant created with their technology in a US first at  NewYork-Presbyterian/Weill Cornell Medical Center  this August.

Heller’s journey from cancer patient to her own advocate for the latest in personalized healthcare is a triumph — certainly for her personally, as following recovery from the implantation of her fully custom device she has regained nearly the full range of motion, but also for the technology and business behind the implant’s creation. 3D printing is leading to unprecedented personalization of healthcare, as unique geometries can be created to precisely fit individual anatomy, rather than the traditional shaping of the person’s anatomy to a one-size-hopefully-fits-most device from a shelf of best-fit. The advances possible through bringing additive manufacturing into hospital and healthcare settings are cutting-edge, allowing for new tools in healthcare providers’ medical kits; but there’s often a hitch in the form of regulation. New technologies require a deep look from a regulatory point of view, ensuring that they are the best options for living, breathing humans as well as for insurance purposes. In the case of this implant, a special approval from the US FDA was required to move forward with the surgery; Heller was fortunate in having a great medical team and technology provider to turn to in gaining these approvals.

To learn more about all that went into the US-first procedure and the development of the implant, I turned recently to  Dean S. Carson, PhD, Vice President, US Operations for Anatomics, who was kind enough to answer A Few Questions For me regarding this case.

After the patient heard about the story of the first sternum implant from Anatomics, how did she take this information to lead to her own procedure?

“After recovery from the successful resection surgery, Penelope was cancer free but continued to experience issues with breathing and range of motion. She began searching for fellow patients who had similar surgeries to gauge their outcomes and found articles about a similar surgery conducted in Spain using an implant developed by Anatomics.  She and her mother reached out to the company and after learning that Anatomics's custom implants are not approved in the US, began working on the process to gain access to the implant via the FDA's Expanded Access (Compassionate Use) Program. The process involved identifying a doctor who would perform the procedure and then getting approvals from both the FDA and the hospital.”

Is there a difference in the procedure for implanting a custom versus an off-the-shelf implant for the medical team?

“Typically, custom devices are easier to implant because they are designed to match each individual patient's anatomy. It is often necessary for the medical team to modify a patient's anatomy to ensure that off-the-shelf implants fit.”

How long did the creation of the customized implant take, from CT scan to final 3D printing?

“Custom sternum and ribcage implants take 2 days of design work, 1 day to 3D print, 3 days to post-process, 3 days to add the PoreStar coating, and  2 days to sterilize.”

How long did the surgery take? How did the surgical team prepare ahead of time?

“The resection took approximately 2 hours and the implant placement took less than 2 hours.”

How has the recovery process been compared to that for the first implant procedure?

“For years after the initial procedure, Penelope continued to experience pain and could not participate fully in some of her favorite activities, like spinning pottery, yoga, and rock climbing. Opto-electronic Plethysmography (OEP) test results taken before the surgery to evaluate ventilation via external measurements of the chest wall surface motion showed that she was only able to move 64% of the volume of oxygen compared with others of her age range. Now she can move nearly 100%.”