Printed Heart Models Listed as Class 1 Medical Devices

When physicians at the New York-Presbyterian/Morgan Stanley Children’s Hospital were faced with performing complex heart surgery on a 1-week-old baby born with congenital heart disease, they turned to 3D printing to prepare for the procedure. The hospital sent a CT scan of the heart to Materialise, which created a digital 3D model of the heart using its Mimics solution, and then printed a high detailed replica. The doctors used the model to find a way to repair all of the heart defects in one procedure.

Materialise has now listed its 3D-printed cardiovascular HeartPrint models, a service provided as part of the Mimics Innovation Suite, as Class 1 medical devices in the U.S. and European Union markets. The new classification allows the company to add HeartPrint models to its pre-operative planning offerings.

“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 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 New York-Presbyterian / Morgan Stanley Children’s Hospital.

Having a pre-procedure roadmap is invaluable. In the case of the baby in New York, there were not only holes in a heart, but the child’s heart chambers were in an unusual formation.

“In the past, we had to stop the heart and look inside to decide what to do. With 3D printing technology, we are able to look at the inside of the heart in advance, giving us a road map for the surgery,” Bacha said in a statement.

The success at New York-Presbyterian is not an isolated case. Last year, we wrote about efforts at Phoenix Children’s Hospital to use 3D-printed heart models for surgery preparation. Earlier this year, surgeons in Barcelona used a similar model to practice a complex tumor-removal surgery several times before successfully performing the procedure on a 5-year-old boy.

Source: Materialise