Preliminary three-month results from the first five human implantations of StentIt’s resorbable fibrillated scaffold (RFS) reveal a technical success rate of 100% and no device- or procedure-related serious adverse events at 30 days in patients with below-the-knee (BTK) chronic limb-threatening ischaemia (CLTI).
Marianne Brodmann (Medical University of Graz, Graz, Austria) shared these early findings from the VITAL-IT 1 study as a first-time data release at the 2026 Leipzig Interventional Course (LINC; 27–31 January, Leipzig, Germany).
The RFS device is a bioresorbable stent built from microfibres, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patients’ own cells 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.
At LINC, Brodmann expanded on some key characteristics of the RFS. “The device is a fully electrospun tubular conduit with fibrous micro-architecture and a strutless design,” the presenter noted, also highlighting the implant’s suitability for transcatheter delivery due to a balloon-expandable design.
Furthermore, Brodmann shared that the RFS provides a template for colonising cells to induce neotissue formation, and has been designed to enable tissue regeneration with no need for drug elution.
The presenter added that the RFS has a unique degradation profile, showing maintained mechanical support at three months and complete dissolution at 12 in preclinical studies.
Regarding the mechanism of action, Brodmann noted that the RFS allows for reorganisation of the fibrous network upon inflation by the balloon, allowing for geometrical expansion.
As for the data, Brodmann highlighted long-term preclinical follow-up showing rapid tissue integration and regained arterial compliance. Early evidence is also available showing reconstruction of protective tissue barriers following use of the RFS, the presenter continued, highlighting the presence of elastin and endothelial cells at three months in animal studies.
At LINC, Brodmann shared preliminary three-month results of the first-in-human RFS scaffold implantations in five patients with BTK CLTI. The data are from the VITAL-IT 1 prospective, non-randomised feasibility study, which was designed to evaluate the RFS device in up to 10 patients. This single-centre study is being conducted at the Medical University of Graz. All study patients will be monitored for 24 months.
In terms of patient demographics for the data presented, Brodmann noted that all five patients were male, with a median age of 65 years. All patients had Rutherford classification 5, with a median ankle-brachial index (ABI) of 0.44 and a median wound area of 600mm2.
On target lesion characteristics, Brodmann noted a median target lesion diameter of 3.1mm and a median target lesion length of 15mm. Calcification was mild in four patients and severe in one, with the majority of vessels categorised as TASC A. Vessel preparation was performed successfully in all five patients.
Sharing interim primary performance and safety results, Brodmann revealed at LINC that all five patients met the study’s primary outcome measures—comprising the primary performance endpoint of uniform balloon expansion, successful deployment of the RFS implant, successful withdrawal of the RFS delivery system, and final residual area stenosis of less than or equal to 50%—and the 30-day safety endpoint of freedom from major adverse limb event and perioperative death at 30-day follow-up.
“The first-in-human VITAL-IT 1 study is currently ongoing to assess feasibility of implantation and primary safety of the device at 30 days,” Brodmann said in her concluding remarks. “The first cases show technical success and primary safety; ongoing enrolment and follow-up are expected.”
