Materialise Receives FDA Clearance for 3D Printed Patient-Specific Surgical Guides for Pediatric Ulna and Radius Osteotomies

One of the many industries that Belgium-based Materialise provides 3D printing solutions for is the healthcare sector. After announcing a partnership with medical product development company Kapstone Medical and a five-year deal with Medical Dynamic Marketing, Inc. in Japan, the Materialise CEO called for improved clinical measurement standards to help expand medical 3D printing. A few months ago, Materialise launched AnatomyPrint, its 3D printing solution for making medical models, and has upgraded its biomedical Mimics Innovation Suite software several times, rolling out the Mimics Innovation Suite 19 this past summer. Recently, a surgeon with the Hampshire Hand Surgery Clinic used the Mimics software to design patient-specific wrist osteotomy guides for a complex case.

Speaking of osteotomy guides, Materialise announced today that it has been granted FDA clearance for 3D printed patient-specific surgical guides for ulna and radius pediatric osteotomies, to help orthopaedic surgeons plan and execute complex cases for children as young as seven years old. Surgeons can combine the use of 3D printed guides with 3D preoperative planning, and increase their confidence in the outcome before and during these difficult surgical cases.

Distal Radius Correction

Bone deformities in children’s upper extremities are not easy to visualize and fix, especially when the patient has lost the ability to rotate their forearm. Before now, doctors used X-ray images to draw freehand surgical plans for pediatric osteotomies, and it’s easy to believe that even seasoned surgeons feel a little trepidation before going into the operating room with just a hand-drawn medical model. Unfortunately, about 60% of distal-radius osteotomies didn’t get the planned correction completely right. But thanks to Materialise’s continuing medical 3D printing advances, patient-specific 3D printed medical guides for these difficult pediatric surgeries can now be made, and for a reasonable cost as well.

Materialise has consulted on over 1,000 clinical osteotomies for adult patients, so Clinical Engineers with the company are more than prepared to offer their 3D printed surgical planning expertise to pediatric surgeries as well.

Osteotomy guide, Hampshire Hand Surgery Clinic case

Materialise works with the surgeon to 3D print the patient-specific surgical guides so they are perfectly designed to fit on the actual patient’s bone, which can lead to better, more predictable surgical outcomes. In the difficult case at the Hampshire Hand Surgery Clinic mentioned earlier, Materialise Clinical Engineers scanned the patient’s fractured wrist and the healthy one, planned out the optimal cuts, and designed the surgical guides, which helped Consultant Orthopaedic Surgeon Alistair Phillips perform this first of its kind, successful surgery.

Bryan Crutchfield, Vice President and General Manager for Materialise North America, said, “In bringing this 3D printing technology to pediatric surgery, surgeons will have access to our clinical engineers’ wealth of experience developing osteotomy guides, helping them perform even the most complex bone corrections that will have a positive impact on the rest of the child’s life.”

Materialise has leveraged over 26 years of 3D printing experience, and has spent nearly a decade working with hospitals and surgeons around the globe to perfect its 3D printed osteotomy guide process for adult cases of complex bone corrections. The company hopes to be able to make a positive difference in the lives of children who need bone corrections by expanding the technology to pediatric surgeries.

You can see Materialise’s full range of orthopaedic end-to-end 3D printing solutions, including its patient-specific medical devices, at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting this week in San Diego. Discuss in the Materialise forum at 3DPB.com.