Anatomics’ custom 3D-printed sternum implant used in US 1st replacement procedure

Anatomics said this month that a custom 3D-printed implant it created was successfully implanted to replace the sternum and partial ribcage of a 20-year old patient who had lost significant bone mass to Chondrosarcoma, touting the procedure as a 1st for the US.

The implant was composed of composite titanium and porous polyethylene designed using high-resolution CT scans of the patient’s chest, approved by an operating surgeon. The implant was only the 2nd of its kind to use the company’s PoreStar technology, though Anatomics has been innovating in the field of 3D printing for over 2 decades.

Anatomics has been making 3D printed medical models for 25 years, CEO Dean Carson told MassDevice.com in an interview, though its technology has seen significant leaps in quality since then.

“The 3D imagery capability 25 years ago were nowhere near at the high quality they are today. In order to provide the final product of a patient-specific implant it’s necessary to have high resolution CT imagery. Now the technology has advanced to a point where we can be very confident that what we’re looking at is a good representation of the patient’s anatomy,” Carson said.

Carson thinks that the technological advances will have a significant impact on procedures and increase the use of bespoke implants, removing the need to rely on off-the-shelf implants which are currently the standard of care.

“The technology has the ability to alter the approach that a surgeon takes to treating a patient. I think that’s what’s so powerful about this technology – we’re seeing a shift in the medical field approach to treating patients. It’s really driven by the ability to have high quality patient-specific implants available for treating their patients,” Carson said.

The bespoke nature of the implant and advanced technology had a significant impact in terms of pain relief and improved quality of life, according to patient Penelope Heller, who also spoke to MassDevice.com about the procedure.

Heller underwent a procedure in 2014 to remove a malignant bone tumor after a diagnosis of Chondrosarcoma, a rare cancer affecting bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal. But the surgery left Heller with a significant amount of pain and discomfort, she said.

“The reason I sought another surgery is that over the years I reached a level of discomfort and chronic pain that I found to be just unacceptable and I figured I’d look into options,” Heller said. “I contacted Anatomics, told them my story. I had contacted Anatomics in Australia and didn’t even know that they had offices in the States. At first I was told that Anatomics doesn’t have any FDA approval so it might be difficult.”

CEO Carson eventually heard Heller’s story and gained interest – and though the technology is not currently cleared by the FDA for general use, a procedure was able to be performed under the FDA’s Expedited Access, or compassionate use, pathway.

A procedure to revise the prior implant was performed on August 2 at the NewYork-Presbyterian/Weill Cornell Medical Center, led by Dr. Jeffrey Port. Heller said she was able to tell a significant difference within approximately 2 weeks.

“My first surgery was on September 15, and at Thanksgiving I was still taking painkillers – I was taking narcotic painkillers a couple times a day and Tylenol pretty much around the clock,” Heller said. “I had my [second] surgery on August 2, and I stopped all narcotic painkillers, I want to say, on August 15 or 16 … I stopped taking Tylenol in the week after that. That speaks for itself in terms of pain.”

Heller said that outside of reduced narcotic use, she was also taking steps to explore quantitative results after the procedure, having contacted labs at Columbia Presbyterian Hospitals OEP lab to explore pre and post-op results.

“I contacted the researcher there and I got that testing done before my surgery in addition to a pretty standard exercise stress test with some breathing measurements as well. Those results are very interesting and pretty different pre-op and post-op,” Heller said. “My favorite result of that test is that before this August 2 operation, I was moving 64% of the predicted air volume for my age and height and weight, and post-op I’m moving, I think 98% of that number – 98% of the predicted number. That, to me, seals the deal and makes me even more excited about the choice that I made to get the surgery, that one number was really exciting to me.”

Carson said that the company is also dedicated to collecting objective data as it looks to explore the quantitative benefits Heller received from the custom implant it produced, and it hoped those results would help support regulatory clearance.

“That objective data is very important for us and also for the regulators,” Carson said.

The company has a submission for FDA 510(k) approval pending with the agency, Carson said, and is continuing to collect data on its PoreStar platform.

“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,” Anatomics’ exec chair Paul D’Urso said in a press release.

The post Anatomics’ custom 3D-printed sternum implant used in US 1st replacement procedure appeared first on MassDevice.

from MassDevice http://ift.tt/2zUcMHn