The MAJESTIC trial, designed to evaluate the safety and performance of the Boston Scientific’s peripheral drug-eluting stent system, is projected to enroll 55 patients across 15 centres in Europe, Australia and New Zealand.
The Innova drug-eluting stent system is designed to restore blood flow in arteries above the knee, specifically the superficial femoral artery and proximal popliteal artery. The stent features a unique drug-polymer combination, intended to facilitate optimal release of the drug and prevent restenosis of the vessel. The first implant was performed by Andrew Holden, director of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.
“The complex anatomy of the superficial femoral artery above the knee and the dynamic forces created by flexion of the knee create a challenging environment for implants like stents, leading to the potential risk of stent fracture and higher rates of restenosis,” said Stefan Muller-Hulsbeck, deputy chairman Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Germany, and the principal investigator of the MAJESTIC trial. “The Innova drug-eluting stent system combines the benefits of the clinically-proven drug paclitaxel with architecture and stent design purpose-built for use in the superficial femoral artery and proximal popliteal artery. The deliverability, flexibility and durability in combination with the anti-restenotic characteristics of the Innova drug-eluting stent system make it ideal for use treating lesions in these critical arteries,” he explained.
The Innova drug-eluting stent system consists of a paclitaxel-coated, nitinol, self-expanding stent loaded on an advanced, low-profile delivery system. The innovative stent architecture features a closed-cell design at each end of the stent for more consistent deployment, and an open-cell design along the stent body for improved flexibility and fracture resistance. Deployment accuracy is facilitated by a tri-axial catheter shaft designed to provide added support and placement accuracy.