Materialise NV (Leuven, Belgium), a supplier of additive manufacturing software and 3D printing services to the medical and industrial sectors, has listed its 3D-printed cardiovascular HeartPrint models as a medical device in the U.S. and EU markets. The company has used 3D printing to fabricate anatomical models for educational and research purposes for many years; this move strengthens its unique position in the market, says Materialise in a press release, and is a natural extension of the Mimics Innovation Suite of software for medical image processing, which has 510(k) clearance and a CE mark.
By listing HeartPrint as a Class I medical device, Materialise is able to add HeartPrint models to its portfolio of pre-operative planning tools. The 3D-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 patient.
"Where I think 3D printing will take us clinically is to the next generation of imaging. As we've seen in the history of medicine, the better our imaging, the more precise we are pre-operatively to be able to say what operation we're going to do," said David Morales, MD, Chief of Cardiovascular Surgery for the Heart Institute at Cincinnati Children's Hospital Medical Center.
The use of 3D printing in the medical arena continues to make headlines. One recent article told the story of a 1 week old born with a complex form of congenital heart disease. The day after he was born, an extremely low-dose CT scan of the chest was acquired and the data were sent to Materialise, where a digital 3D-model of the baby's heart was used to 3D print a replica showing even the smallest details of the organ. With the walnut-size model in hand, clinicians at the New YorkPresbyterian Morgan Stanley Children's Hospital were able to determine a solution for repairing all of the baby's defects in a single procedure.
"After the success of this surgery, it's hard to imagine entering an operating room for another complex case without the aid of a 3D-printed model. It's definitely going to be standard of care in the future and we're happy to be leading the way," said Dr. Emile Bacha, a congenital heart surgeon and Director of Congenital and Pediatric Cardiac Surgery at NewYorkPresbyterian Morgan Stanley Children's Hospital.
Regulatory entities have raised concerns about 3D printing in a clinical environment, as a validated quality system is critical for ensuring accuracy and safety. Materialise says it is the only company that has actively addressed these issues with its Mimics Innovation Suite for segmenting medical image data and Streamics, which is dedicated to automating, controlling, and tracking the 3D-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. This makes it easier for Materialise and our customers to bring patient-specific, 3D-printed treatments to the market. It's important for us to stay ahead of the regulatory requirements," says Koen Engelborghs, Director of Biomedical Engineering at Materialise.