Boston Scientific Corp. on Monday announced CE Mark approval and the European market launch of its Innova Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee.
Specifically, the stent is used in the superficial femoral artery and the proximal popliteal artery. Boston Scientific said it plans to sell the stent immediately in Europe and other CE Mark countries.
"Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates," said Mauro Gargiulo, M.D., physician at Sant'Orsola-Malpighi in Bologna, Italy, who performed the first procedure using the Innova Stent in Europe. "The unique design and stent architecture used in the Innova Stent platform provide excellent radial strength, flexibility and durability which are critical to sustaining patency in treated SFA and PPA lesions. The excellent deliverability and placement accuracy add another significant level of benefit, especially when accessing challenging and long lesions."