StentIt’s Resorbable Fibrillated Scaffold Evaluated to Treat CLTI BTK

June 26, 2025—StentIt, a Netherlands-based developer of stents with regenerative properties, announced the successful implantation of its resorbable fibrillated scaffold (RFS) as part of the VITAL-IT 1 study. The first-in-human feasibility study is composed of patients with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK) treated with the RFS implant.

According to the company, revascularization was achieved in patients with the RFS implant using an endovascular approach to restore the blood flow to the foot.

The prospective, nonrandomized VITAL-IT 1 feasibility study is designed to evaluate StentIt’s RFS device in up to 10 patients with BTK CLTI.

This single-center study is being conducted at the Medical University of Graz, Austria. All study patients will be monitored for 24 months, noted the company’s press release.

StentIt stated that the RFS device is a bioresorbable stent built from microfibers, providing structural support to instantly open, and facilitate the reconstruction of the artery. The implant’s porous design is intended to allow a patient’s own cells to infiltrate into the mesh, triggering the formation of new vascular tissue. While the artery is being reconstructed from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time, stated the company.

Professor Marianne Brodmann, MD, Head of Division of Angiology at the Medical University of Graz, commented on VITAL-IT 1 and the RFS in the press release.

“This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients,” stated Prof. Brodmann. “This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions.”