“3D Printing and Personalized Healthcare is Here to Stay” – Anatomics Shares Deeper Look at US-First 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.”

Will this procedure lead to potentially more personalized healthcare in medical centers using 3D technologies?

“Additive manufacturing has penetrated in to almost all areas of medicine and hospitals across the country and the globe are now utilizing 3D printing for a broad number of applications. Patients want to be treated with evidence based care, but they also want treatments tailored to their specific needs. 3D printing and personalized healthcare is here to stay. While Anatomics cannot comment on the New York Presbyterian’s behalf about their future use of the technology, we hope to bring this technology to patients in need across the country as far as the FDA allows under its Expanded Access (Compassionate Use) Program.”

How does regulatory approval impact personalized healthcare solutions?

“For cases involving an unapproved custom device, the FDA’s Expanded Access Review Division provides the ability to quickly obtain approval to ensure patients can access the treatments they need. Otherwise, there are clear pathways to receiving FDA approval including 510(k) for medical devices that are substantially similar to existing products on the market or Premarket Approval (PMA) for novel devices that differ substantially from existing products. The FDA have made strong commitments to embracing the shift towards personalized healthcare, especially as advanced manufacturing techniques have been adopted more broadly. The FDA is currently working with multiple stakeholders to develop new regulatory pathways to help streamline the approval process for personalized healthcare solutions. An example of this is the FDA’s recent publication of a Draft Guidance on Additive Manufacturing of Medical Devices as well as the formation of the Additive Manufacturing Working Group and publication of multiple scientific articles.”

When is full FDA approval expected for Anatomics’ PoreStar technology?

“We expect the FDA to provide Anatomics with marketing approval for the use of our PoreStar technology in custom craniomaxillofacial surgery by the end of this year. We will then begin looking at filing additional submissions to receive marketing approval for various other uses of this technology, including orthopedic, cardiothoracic, and neurosurgical applications.”

Anatomics has not shied away from difficult cases bringing patient-specific 3D printed implants to those afflicted with rare forms of cancer, like Heller. The company continues to innovate, collaborate, and, importantly, raise the profile of personalized care in advanced medical treatment.

Heller’s team worked additionally with Columbia University researchers to determine if the original prosthesis was causing abnormal chest wall movement which may have contributed to her symptoms. By using a sophisticated motion analysis system called Optoelectronic Plethysmography (OEP), this team was able to reconstruct Heller’s chest wall in 3D and analyze the movement of her chest wall where the old prosthesis was and new 3D printed implant would be placed.

Regarding the patient’s progress with her 3D printed prosthesis, we heard more from Heller’s specialist in monitoring the cardiopulmonary aspects of her recovery, Aimee M. Layton, Ph.D., RCEP, Cardiopulmonary Laboratory Director and Associate Research Scientist for the Faculty of the Department of Medicine-Division of Pulmonary, Allergy, Critical Care at Columbia University Medical Center. Dr. Layton tells us:

“We performed motion analysis research called Optoelectronic Plethysmography (OEP) to reconstruct Penelope’s chest wall in 3D and analyze her breathing mechanics as she exercised. This allowed us to isolate the area of the chest wall where she was feeling pain and determine if that area was moving abnormally compared to the surrounding tissue. We then compared that abnormal movement to Penelope’s ability to get carbon dioxide out of her body and oxygen into her body. Results are still being analyzed but the preliminary data suggests that what Penelope was feeling was beyond just discomfort, she had real chest wall movement impairment from the original prosthesis and such impairment looks like it may have been corrected by the new 3D printed prosthesis. We are looking forward to sharing the final results in the near future.”

You can learn more about Heller’s story in her own words in this video from Anatomics:

As 3D printing continues to make headway in hospitals around the world, care can continue to become more customized — but it will take dedicated efforts from medical care providers, businesses, and regulators to reach its deep potential.

Discuss this and other 3D printing topics at 3DPrintBoard.com, or share your thoughts below.

[Images: Anatomics]


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