Boston Scientific Begins Clinical Trial Of Innova Peripheral Vascular Drug-Eluting Stent
October 14, 2013 — Launching a clinical trial expected to serve as the foundation for global regulatory approvals, a physician in Auckland, New Zealand has performed the first patient implant of the Boston Scientific Corp. Innova Drug-Eluting Stent (DES) System.
The Majestic trial, designed to evaluate the safety and performance of the first Boston Scientific peripheral drug-eluting stent system, is projected to enroll 55 patients across 15 centers in Europe, Australia and New Zealand.
The Innova DES System is designed to restore blood flow in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The stent features a 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, M.D., and director of interventional radiology, Auckland City Hospital, Auckland, New Zealand.
The Innova DES System consists of a paclitaxel-coated, nitinol, self-expanding stent loaded on a 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. A tri-axial catheter shaft designed to provide added support facilitates deployment accuracy.
The Innova DES System is an investigational device and is not available for use or sale.
For more information: www.bostonscientific.com