A recent example of Materialise’s 3D printed HeartPrint for a new born baby. Image: Materialise
Materialise is leading the way in the application of 3D printing in the medical and health industries from solutions in orthopaedics to breakthroughs in fractures. Now the company has listed its 3D-printed cardiovascular HeartPrint models as a medical device in the USA and EU markets.
Created from medical image data to provide an accurate model of the heart, surgeons can use the device to determine he best treatment per individual case. By listing HeartPrint as a Class 1 medical device, the Company can now use the device in pre-operative planning.
This development is a natural extension of its Mimics Innovation Suite of software for medical image processing which has an existing 510(k) clearance and CE mark.
David Morales, MD, Chief of Cardiovascular Surgery for the Heart Institute at Cincinnati Children's Hospital Medical Centre said: “Where I think clinically 3D 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.”
Concerns have been raised by regulatory bodies about 3D printing in a clinical environment as devices must undergo a strict validation process to ensure accuracy and safety. Materialise addresses this with the Mimics Innovation Suite for splitting the medical image data and Streamics, which is dedicated to automating, controlling and tracking the 3D printing process to ensure 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,” says Koen Engelborghs, Director of Biomedical Engineering at Materialise. “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.”
Materialise has a long track record of providing cutting-edge, 3D visualisation and printing solutions to their extensive list of hospital, academic and medical device customers. Most recently the company utilised the HeartPrint model to help a 16 year old patient with a heart tumour.