Terumo Europe recently announced the initiation of e-MISAGO, one of the largest registries in the peripheral endovascular field. At the same time, the product range of Misago peripheral self-expanding stent has been expanded to cover wider indications.
e-MISAGO is a non-randomised, prospective, multicentre, observational registry with the main objective to validate the safety and efficacy of Misago Stent System in real-world patients. More than 100 European centres are expected to take part in e-MISAGO during the enrolment period scheduled until the end of September 2010, and targeting more than 2000 patients. The patients will be followed up at 30 days and 12 months.
The Misago stent has already been studied in the MISAGO 1 trial which enrolled 55 patients (treated with 83 Misago stents). At six months follow-up, the clinical outcomes were excellent, with repeat revascularisations needed in only 3.6% of the patients and a restenosis rate of 8.5%. The results of an ongoing the MISAGO 2 study which enrolled 770 patients in 79 centres will be presented at CIRSE 2009 and at TCT 2009.
In addition to the 6 and 8mm diameter Misago stents already available, 9 and 10 mm diameters, mainly dedicated to iliac arteries, have been added to the product range. The new items incorporate the same top class stent flexibility to fit tortuous or bent anatomy. The unique rapid exchange delivery system is expected to significantly enhance stent implantation also in iliac arteries, particularly in the crossover approach.