STENTiT, a medical device company based in Eindhoven, The Netherlands, has achieved a significant clinical milestone with the successful implantation of its first Resorbable Fibrillated Scaffold (RFS) in a patient with chronic limb-threatening ischemia (CLTI) below-the-knee. The procedure marks the initiation of the VITAL-IT 1 study, a first-in-human clinical trial evaluating this novel regenerative stent technology.
The RFS represents a new class of bioresorbable stents constructed from microfibers that provide immediate structural support to open blocked arteries while facilitating natural tissue regeneration. The device's porous design allows patient cells to infiltrate the mesh, triggering the formation of new vascular tissue. As the artery reconstructs from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time.
"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. "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."
Clinical Trial Design and Objectives
VITAL-IT 1 (NCT07006467) is a prospective, non-randomized feasibility study designed to evaluate the STENTiT RFS device in up to 10 patients with below-the-knee CLTI. The single-center study is being conducted at the Medical University of Graz, Austria, with all patients monitored for 24 months to assess safety, feasibility, and signs of clinical benefit.
Prof. Marianne Brodmann, MD, Head of Division of Angiology at the Medical University of Graz, emphasized the clinical significance of this approach. "This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients," she said. "This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions."
Addressing Critical Medical Need
CLTI represents the end stage of peripheral artery disease, characterized by constant rest pain, non-healing ulcers, or gangrene caused by critically reduced blood flow to the foot. The condition affects an estimated 3.5 million people in Europe and the United States and leads to more than 250,000 amputations per year. Despite advances in the field, long-term patency in below-the-knee vessels remains poor, leaving many patients with limited durable treatment options.
The regenerative approach offered by the RFS device aims to address these limitations by combining immediate vascular support with the potential for long-term tissue regeneration. Unlike traditional permanent stents, the RFS is designed to facilitate natural healing while eliminating the long-term presence of foreign material in the vessel.
Technology and Development Background
STENTiT was founded in 2017 as a spin-off from the Eindhoven University of Technology and is developing a new class of stents with regenerative properties to set new standards in cardiovascular treatment. The company is supported by the European Innovation Council's EIC Accelerator program and has been selected for the 2025 MedTech Innovator cohort.
The successful first patient treatment represents a crucial step in translating this regenerative technology from laboratory development to clinical application, with the potential to transform treatment approaches for patients with advanced peripheral artery disease.
