An example of a patient-specific airway stent developed at Cleveland Clinic.
An example of a patient-specific airway stent developed at Cleveland Clinic.

3D printed airway stents approved by FDA

The U.S. Food and Drug Administration (FDA) has cleared patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea, M.D. The stents are used to keep open the airways of patients with serious breathing disorders, such as those caused by tumors, inflammation, trauma or other masses.

Until now, the patient-specific devices were being implanted under FDA’s compassionate use program, which allows patients who have failed all available forms of treatment to receive investigational ones not yet available to the public.

Standard airway stents come in a limited number of sizes and shapes and are generally designed for larger airways. However, no two patient anatomies are alike, making it difficult to get a perfect fit, especially for those with complex conditions. Even in parts of the airways that are easily accessible, ill-fitting standard stents can result in stent kinking and bending as well as airway complications such as growth of new tissue, mucus impaction and tissue death.

The patient-specific stents developed by Dr. Gildea and his engineering team are designed using CT scans and proprietary 3D visualization software. The molds for the stents are then printed using a 3D printer and injected with medical-grade silicone. This process allows them to perfectly fit a patient’s anatomy. “Breathing is something many people take for granted, but for many of these patients, every breath can be a struggle. It’s been gratifying to see patients receiving the customized stents feeling relief right away.” said Dr. Gildea, section head of bronchoscopy at Cleveland Clinic. “We are excited to be able to bring this technology to more patients across the country and grateful for the patients and donors who have worked with us to help pioneer this technology.”

The patient-matched stents are made specifically to fit the patients’ airways.
The patient-matched stents are made specifically to fit the patients’ airways.
Source: Cleveland Clinic

Another advantage of the patient-specific silicone stents is they have the potential to be more tolerable than traditional silicone stents, which, in certain patients, may have to be frequently changed or cleaned due to problems from a poor fit. In studies, the patient-specific stents lasted, on average, about a year versus 90 days for stock stents. Furthermore, the patient-specific stents exhibited shorter procedure times and improved patient-reported symptoms, leading to a reduced need for stent changes and modifications.

It’s estimated that about 30,000 airway stents will be implanted in the U.S. in 2020. Patient-specific products manufactured with 3D printing, including the airway stents, were named as one of the top 10 innovations at Cleveland Clinic’s annual Medical Innovations Summit in 2018. Dr. Gildea was also the recipient of the Outstanding Innovation in Medical Device award at the 2018 annual Inventor Awards Reception held by Cleveland Clinic Innovations.

With personalized medical devices more common in orthopedics, the patient-specific stent was developed and FDA cleared by an engineering team inside an orthopedic-focused Cleveland Clinic subsidiary. A new subsidiary named VisionAir Solutions will be formed around the technology with the sole mission of bringing more personalized medical devices to interventional pulmonologists and the patients who need them. By the end of the first quarter of 2020, this new spin-off company plans to begin providing the personalized stents to patients in a controlled launch at many of the country’s top medical institutions.

Subscribe to our newsletter

Related articles

3D-printed parts could make ventilators safer

3D-printed parts could make ventilators safer

Researchers at Duke University have engineered a workaround to make ventilators safer and more efficient when splitting them between patients.

Using 3D printing to study common heart defect

Using 3D printing to study common heart defect

Researchers have combined machine learning, 3D printing and high performance computing simulations to accurately model blood flow in the aorta.

Artificial pericardial tissue from the 3D printer

Artificial pericardial tissue from the 3D printer

In the PolyKARD project, biomimetic polymers are being developed that can imitate the mechanical properties of pericardial tissue.

Predicting leaky heart valves with 3D printing

Predicting leaky heart valves with 3D printing

Researchers have created a novel 3D printing workflow that allows cardiologists to evaluate how different valve sizes will interact with each patient's unique anatomy, before the medical procedure is actually performed.

3D-printed cardiac patches for cardiovascular diseases

3D-printed cardiac patches for cardiovascular diseases

Bioprinted 3D cardiac patches could reverse scar formation and promote myocardial regeneration after heart attacks.

Using AI to predict 3D printing processes

Using AI to predict 3D printing processes

Engineers use Frontera supercomputer to develop physics-informed neural networks for additive manufacturing.

Medical technologies that come out of the printer

Medical technologies that come out of the printer

Fraunhofer-Gesellschaft's German-Polish High-Performance Center brings additive manufacturing to medical technology – first demonstrators will already be presented by the end of 2021.

Printable biosensors could make surgery safer

Printable biosensors could make surgery safer

Researchers have developed fully printable biosensor made of soft bio-inks interfaces with a pig heart.

Deep learning Assesses risk of cardiovascular disease

Deep learning Assesses risk of cardiovascular disease

A team of engineers from Rensselaer Polytechnic Institute and clinicians from Massachusetts General Hospital developed a deep learning algorithm that can help assess a patient's risk of cardiovascular disease with the same low-dose computerized tomography (CT) scan used to screen for lung cancer.

Popular articles

Subscribe to Newsletter