Additive manufacturing creates customized, FDA-approved stents

In the medical sector, additive manufacturing has a real trump card up its sleeve: it enables the design of customized devices, entirely manufactured based on the patient’s own anatomy. There are many applications, from anatomical models for the surgeons to human tissues, prosthetics and orthotics. Some 3D printing materials even have characteristics akin to human bones, as for example PEEK, which means that implants can be created that are readily assimilated by the body.

 

Stents approved by the Food and Drug Administration (FDA)

In the United States, more specifically at the Cleveland Clinic, a team of researchers and physicians have obtained FDA approval for stents designed by additive manufacturing and silicone injection. These devices, also known as vascular endoprostheses, are used to keep a cavity open – in this case, an artery. This approval therefore authorizes their marketing, relieving many surgeries for tumors, trauma or serious inflammation.

 

Dr. Gildea, head of the bronchoscopy department at the Cleveland Clinic, is behind this project. It started from a simple observation: traditionally manufactured stents are not adapted to the patient’s morphology and are often the same shape. Adjusting them is very complicated and their placement can lead to many complications, some of which very serious. It was therefore high time a solution was found that was customized to each person. Additive manufacturing rapidly prevailed, demonstrating its capacity to personalize a product, regardless of the quantity produced.

 

The stent mold was 3D-printed (photo credits: Cleveland Clinic)

Production of custom-made stents

The stent manufacturing process begins with the use of scanners and proprietary 3D visualization software. From the 3D model generated, the medical profession can 3D-print a made-to-measure mold into which silicone is injected to create the finished stent. Besides being tailored to the end patient, the device also has a longer lifetime: a traditional stent typically needs to be replaced every 3 months, compared to once a year for a customized stent.

“Breathing is something that many people take for granted, but for many of these patients, each breath is a struggle. It is very rewarding to see that those patients receiving customized stents are experiencing immediate relief,” said Dr. Gildea. We are delighted to be able to make this technology available to a larger number of patients across the country.”

30,000 vascular endoprostheses should be on the market this year in the United States via a new entity, VisionAir Solutions. We can therefore hope to see surgeries facilitated and patients in better conditions. Do not hesitate to contact our teams if you too require medical additive manufacturing, our materials can meet those needs!