Dec 22, 2015 | By Kira

In September 2014, Materialise proudly announced that an orthopedic surgeon in Belgium had successfully performed the first total knee surgery that was preplanned using the company’s X-ray Knee Guide Solution, a proprietary technology that allows for the preplanning of knee replacement surgeries as well as 3D printed related surgical guides, based solely on 2D X-ray images rather than more time-consuming and costly CT or MRI imagery. The technology proved to be very promising for patients in need of knee replacement surgeries, and was to be added to Materialise’s growing list of 3D imaging and 3D printing solutions for biomedical and clinical applications.

At that time, Materialise had announced that it intended to continue evaluating the x-ray based knee guide technology, beginning with a limited release of the product in Europe before initiating the regulatory clearance process in the US. However, the disappointing news has come today that the Belgian company has received a Not Substantially Equivalent (NSE) letter from the US Food and Drug Administration (FDA) regarding the their premarket notification submission for the x-ray-to-3D imaging technology in question. This NSE letter effectively prevents Materialise from legally marketing the technology in the US until further approval is obtained.

As the FDA explains, firms must submit premarket information to the FDA in order to receive marketing approval or clearance for their devices prior to commercial distribution. Thus, Materialise submitted their Premarket Notification Submission, also known as a 510k, which is required for devices that are ‘equivalent’ to existing legally marketed devices. In this case, Materialise believed their x-ray knee guide solution to be ‘substantially’ equivalent to their existing 3D surgical planning solutions, which include personalized knee replacement solutions based on CT or MRI images, and that have already been cleared by the FDA.

Once the 510k is received by the FDA, it has two options: to issue a Substantially Equivalent (SE) letter, or a Not Substantially Equivalent (NSE) letter. The latter is used when the FDA determines that the device is not equivalent enough to already legally marketed devices, and therefore cannot be cleared for commercial distribution.

“We are disappointed that the FDA concluded that, based on the information submitted, our X-ray knee guide system cannot be considered as substantially equivalent to our solutions based on CT or MRI images,” said Materialise Founder and CEO Wilfried Vancraen in response to the news. “While this decision will impact the timing of the marketing of our innovative solution in the United States, we will continue to pursue the regulatory clearance process, taking into account the feedback from the FDA.”

Materialise is known for providing additive manufacturing software solutions as well as 3D printing services to a wide variety of industries, in particular to healthcare, biomedical and clinical institutions, through their 3D medial imaging processing and 3D printed surgical simulations. Their 3D printed HeartPrint model was used last year to save a 16 year old who had developed a complicated heart tumor. More recently, Materialise helped to 3D print a surgical model of a six-year-old cancer patient’s knee, effectively her from amputation.

Though the FDA’s NSE letter does appear to be a setback for Materialise, the company will continue to pursue regulatory clearance in order to bring their innovative x-ray knee guide system to the American market and begin helping patients in need. We’ll just have to see what the FDA’s future responses, good or bad, may be.



Posted in 3D Printer Company



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