Boston Scientific Begins MAJESTIC Trial of the Innova DES to Treat the SFA

October 9, 2013—Boston Scientific Corporation (Natick, MA) announced the beginning of the MAJESTIC clinical trial of the company's Innova peripheral vascular drug-eluting stent (DES) system.

The MAJESTIC trial, which is expected to serve as the foundation for global regulatory approvals for the device, is designed to evaluate the safety and performance of the Innova device, which is Boston Scientific's first peripheral DES system. The trial is projected to enroll 55 patients across 15 centers in Europe, Australia, and New Zealand. The first implantation in the MAJESTIC trial was performed by Andrew Holden, MD, who is Director of Interventional Radiology at Auckland City Hospital in Auckland, New Zealand.

According to the company, the Innova DES system is designed to treat superficial femoral artery (SFA) lesions and to restore blood flow in arteries above the knee, specifically the SFA and proximal popliteal artery (PPA). The stent's drug-polymer combination is intended to facilitate optimal release of the drug and prevent restenosis of the vessel.

The Innova system is composed of a paclitaxel-coated, nitinol, self-expanding stent loaded on a low-profile delivery system. The stent architecture features a closed-cell design at each end of the stent for consistent deployment and an open-cell design along the stent body for flexibility and fracture resistance. Deployment accuracy is facilitated by a triaxial catheter shaft designed to provide support and placement accuracy. The Innova DES system is an investigational device worldwide and not available for use or sale, advised Boston Scientific.

Prof. Stefan Muller-Hulsbeck, MD, serves as Principal Investigator of the MAJESTIC trial. He is Deputy Chairman, Vascular Center Diako Flensburg, and Head of the Department of Diagnostic and Interventional Radiology/Neuroradiology at Academic Hospitals Flensburg in Germany.

In the company's press release, Prof. Muller-Hulsbeck commented, “The complex anatomy of the SFA 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. The Innova DES system combines the benefits of the clinically proven drug paclitaxel with architecture and stent design purpose-built for use in the SFA and PPA. The deliverability, flexibility, and durability in combination with the antirestenotic characteristics of the Innova DES system make it ideal for use treating lesions in these critical arteries.”