HeartPrint now listed as a Class 1 medical device

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Materialise has listed its 3D-printed cardiovascular HeartPrint model as a medical device in the USA and EU markets. After years of 3D printing anatomical models for educational and research purposes, the company addressed the need for models that can assist with diagnosing, planning and practicing complex cardiovascular procedures. According to a company press release, this move strengthens the company’s position in the market and 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.

The press release reports that by listing HeartPrint as a Class 1 medical device, the company is able to add HeartPrint models to their offering for pre-operative planning. 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 unique patient.

“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,” comments David Morales, Chief of Cardiovascular Surgery for the Heart Institute at Cincinnati Children’s Hospital Medical Center, USA.

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 is the only company who is actively addressing these issues with their Mimics Innovation Suite for segmenting the 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.