The innovative product is called the Resorbable Fibrillated Scaffold (RFS). In a clinical study, doctors implanted this device in patients with severe blood flow problems in the foot, a condition known as CLTI. In this first round of treatments, doctors were able to restore blood flow using a minor, minimally invasive procedure.
STENTiT's RFS device is a fully bioresorbable stent made from microfibers. This means the synthetic implant gradually dissolves and eventually disappears without leaving any permanent material behind. Like a traditional stent, it helps open up the artery, but thanks to its porous structure, the patient's own cells can grow into the mesh, stimulating the formation of new, healthy vascular tissue. As a result, the blood vessel heals from the inside out.
"Our goal is to bring the next generation of stents with regenerative properties, to guide the body rebuilding functional arteries and improve long-term clinical outcomes," said Bart Sanders, CEO of STENTiT and TU/e alumni. "We are extremely proud reaching this first clinical milestone to show the potential of our technology in providing a durable solution for advanced peripheral artery disease."
Developed at TU/e
The regenerative stent technology has its roots in the Soft Tissue Engineering and Mechanobiology (STEM) group at TU/e. Anthal Smits , a member of this group who is working closely with STENTiT on further development, calls it the culmination of years of research:
"It is very rewarding to see that the innovations that came from our laboratory benches, and the countless experiments and efforts of our researchers and students, now have a direct impact on the lives of patients, thanks to the long-term persistence and vision of the STENTiT team to successfully translate this technology into the clinic."
Clinical trial phase
This early-stage clinical study is designed to test the safety and performance of the RFS device in up to ten patients with severe blood flow problems in the lower leg. This condition is known as chronic limb-threatening ischemia, or CLTI. The arteries below the knee involved in this study are narrower and more fragile than similar ones elsewhere in the body, making it more difficult to keep them open with traditional stents.
The study is being conducted at the Medical University of Graz (Medizinischen Universität Graz) in Austria. All participants will be closely monitored for two years to assess their recovery and the long-term effects of the treatment.
"This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients," said Prof. Marianne Brodmann, MD, Head of Division of Angiology at the Medical University of Graz. "This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions."
Chronic Limb-Threatening Ischemia (CLTI) is the most severe form of peripheral artery disease (PAD), affecting an estimated 3.5 million people in Europe and the US.
The condition is marked by chronic pain, ulcers, or gangrene due to critically reduced blood flow, and is cause for over 250,000 amputations each year. Despite medical advances, durable treatments for below-the-knee vessels remain limited.
About STENTiT
STENTiT, a medical device company based at the High Tech Campus in Eindhoven and a spin-off from TU/e, hopes to address a pressing need with its Resorbable Fibrillated Scaffold (RFS). the clinical study in Graz is officialy called VITAL-IT 1. STENTiT is supported by the European Innovation Council and is part of the 2025 MedTech Innovator cohort .
