A clinical trial evaluating Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) has met its primary endpoint with more than 94% of the lesions treated remaining open at nine months post implantation. This was accompanied by a target lesion revascularisation rate of less than 4%.
Results from the MAJESTIC trial were presented yesterday by Stefan Müller-Hülsbeck, Flensburg, Germany, at the CX Abstracts Session – Peripheral Arterial. The trial enrolled 57 patients across Europe, Australia and New Zealand with an average lesion length of 70.8mm.
“I have not seen clinical data this impressive for a vascular stent that has to perform in an environment as challenging as the superficial femoral artery,” said Müller-Hülsbeck. “Because of forces created by knee flexion, there is an increased risk of restenosis, but we are seeing little evidence of this in the MAJESTIC trial.”
The nine-month follow-up showed no deaths or amputations.
The Eluvia Stent System is a stent purpose-built for the superficial femoral artery and uses a polymer and paclitaxel combination designed to facilitate a sustained drug release to reduce restenosis. The system is built on the Innova Stent System platform consisting of a self-expanding nitinol stent with a paclitaxel-eluting biostable polymer matrix loaded on a low-profile delivery system. According to Boston Scientific, the stent architecture features a closed-cell design at each end of the stent for more predictable deployment, and an open-cell design along the stent body for improved flexibility, strength and fracture resistance.
The Eluvia Stent System is pending CE mark and is not available for use or sale in the USA.
