Materialise 3-D Technology Ups its Medical Technology Role

Belgium-based Materialise NV, a provider of additive manufacturing software and 3-D printing solutions in the medical and industrial markets, has listed its 3-D-printed cardiovascular HeartPrint models as a medical device in the United States and European Union.

After years of 3-D printing anatomical models for educational and research purposes, the company decided to address the need for models that can assist with diagnosing, planning and practicing complex cardiovascular procedures. The move, according to company officials, strengthens their unique position in the market and is a “natural extension” of the company’s Mimics Innovation suite of software for medical image processing, which has existing U.S. Food and Drug Administration 510(k) clearance and CE mark.

By listing HeartPrint as a Class I medical device, the company is able to add HeartPrint models to their offering for pre-operative planning. The 3-D-printed, patient-specific cardiovascular models are created from medical image data to provide cardiologists and surgeons with supplemental information to determine the best treatment for each unique patient.

“Where I think clinically 3-D printing will take us, is to the next generation of imaging. As we’ve seen in the history of medicine, the better and better our imaging, the more precise we are to pre-operatively be able to say what operation we’re going to do,” said
David Morales, M.D., chief of cardiovascular surgery for the Heart Institute at Cincinnati Children’s Hospital Medical Center in Ohio.

The added value of 3-D printed solutions in the medical arena makes headlines daily.

A recent story covered a 1-week-old baby who was born with a complex form of congenital heart disease in which both the aorta and pulmonary arteries arise from the right ventricle as well as a large hole in the heart called a ventricular septal defect (VSD). Only one day after he was born, an extremely low-dose chest computed tomography scan was acquired and data was sent to Todd Pietila, cardiovascular business development manager at Materialise, who created a digital 3-D model of the baby’s heart using Mimics(R) and then 3D-printed a replica where even the smallest details were visible.

With the walnut-size model in hand, the team of clinicians at the New York-Presbyterian/Morgan Stanley Children’s Hospital were able to find a solution for repairing all of the baby’s defects in one procedure rather than the typical series of palliative operations that can be life threatening.

“After the success of this surgery, it’s hard to imagine entering an operating room for another complex case without the aid of a 3-D printed model. It’s definitely going to be standard of care in the future and we’re happy to be leading the way,” said Emile Bacha, M.D., a congenital heart surgeon and director of congenital and pediatric cardiac surgery at New York-Presbyterian/Morgan Stanley Children’s Hospital.

Regulatory entities have raised concerns about 3-D printing in a clinical environment as a validated quality system is critical for ensuring accuracy and safety.

Materialise is addressing these issues with the Mimics Innovation suite for segmenting the medical image data and Streamics, which is dedicated to automating, controlling and tracking the 3-D printing process to ensure traceability and clinical-level quality standards.

“We’re proud that the Mimics Innovation suite is one of the few engineering packages with the appropriate validation to be considered a medical device,” said Koen Engelborghs, director of biomedical engineering at Materialise. “This makes it easier for Materialise and our customers to bring patient-specific, 3-D-printed treatments to the market. It’s important for us to stay ahead of the regulatory requirements. We saw the advantages for patients when HeartPrint models were used in a clinical environment and are looking forward to continuing our collaborations with hospitals to address their 3-D printing needs.”