STENTiT treats first patient with regenerative stent for limb preservation
Ella Day | June 27, 2025 | News story | Research and Development | Cardiology, Medical University of Graz, STENTiT, chronic limb-threatening ischemia, clinical trial, limb amputation, peripheral artery disease, regenerative stent, resorbable fibrillated scaffold
STENTiT has announced the successful first patient implantation of its resorbable fibrillated scaffold (RFS), a new regenerative stent, as part of the VITAL-IT 1 clinical study in Austria. The RFS device, designed for patients with chronic limb-threatening ischaemia (CLTI) below the knee, aims to restore blood flow and preserve limb function in those with advanced peripheral artery disease (PAD).
The RFS is a bioresorbable stent made from microfibres that provide immediate vascular support while encouraging natural healing. Its porous structure enables patient cell infiltration, triggering vascular tissue regeneration from the inside out. Over time, the implant is fully resorbed, which removes the need for permanent materials.
“This marks a significant clinical milestone in our journey to bring regenerative stent technology into practice,” said Bart Sanders, CEO of STENTiT. “Our goal is to help the body rebuild functional arteries and improve outcomes for PAD patients.”
VITAL-IT 1 has enrolled up to ten patients at the Medical University of Graz, Austria. Patients will be monitored over 24 months to evaluate safety, feasibility and signs of clinical benefit.
“This device combines the temporary support of a traditional stent with regenerative healing capabilities,” said Marianne Brodmann, head of angiology at the Medical University of Graz. “It holds real promise for reducing reintervention rates in a high-risk population.”
CLTI, the most severe form of PAD, affects approximately 3.5 million people across Europe and the US and results in over 250,000 amputations annually.
Ella Day
27/6/25
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