The U.S. Food and Drug Administration (FDA) has cleared patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea, MD. Used to keep the airways of patients with serious breathing disorders open—such as those caused by tumors, inflammation or trauma. Until now, the stents were being implanted under the agency’s compassionate use program, which offers patients who have failed all available forms of treatment to receive investigational ones not yet available to the public.
Stents in America
It is estimated that about 30,000 airway stents will be implanted in the United States in 2020 alone.
As it turns out, standard airway stents come in a limited number of sizes and shapes and are generally designed for larger airways. No two patient anatomies are alike, and in many instances, finding a perfect fit represents a medical challenge—especially in the case of complex conditions. Cleveland Clinic reports in its press release that even in easily accessible sections of the airways, ill-fitting standard stents can result in stent kinking and bending as well as airway complications, such as the growth of new tissue, mucus impaction, and tissue death.
Personalized Stents Yield Superior Results
Dr. Gildea and the engineering team at Cleveland Clinic developed patient-specific stents using CT scans and proprietary 3D visualization software. This enables them to exploit 3D printer technology and inject molds with medical-grade silicone. By employing the process, technology, and human ingenuity, the team can produce a stent perfectly suited for an individual’s anatomy.
The personalized stents are potentially 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. The Cleveland Clinic reports that in studies (although they don’t refer to which studies), the patient-specific stents lasted, on average, about a year versus 90 days for stock stents. Moreover, patient-specific stents exhibit shorter procedure times and improved patient-reported symptoms, resulting in fewer demands for stent changes and modifications.
Cleveland Clinic Spin-off Company
Cleveland Clinic established a for-profit venture to capitalize on the FDA clearance and manufacture the stents. Called , the upstart’s mission is to bring more personalized medical devices to interventional pulmonologists and the patients that need them.
Cleveland Clinic reports that the spin-off will be offering personalized stents to the market by the end of Q1 2020. They will start with a controlled launch at many of the nation’s top medical providers.