Terumo Europe Initiates e-MISAGO Registry
July 24, 2009—Terumo Europe NV (Leuven, Belgium) announced the initiation of e-MISAGO, a nonrandomized, prospective, multicenter, observational registry with the main objective to validate the safety and efficacy of the company's Misago peripheral self-expanding stent system in real-world patients. According to the company, more than 100 European centers, which will target more than 2,000 patients, are expected to take part in e-MISAGO during the enrollment period scheduled until the end of September 2010. The patients will be followed up at 30 days and 12 months.
Terumo Europe also announced the expansion of the Misago stent product range to cover wider indications. In addition to the 6- and 8-mm diameter Misago stents already available, 9- and 10-mm diameter stents, mainly dedicated to iliac arteries, have been added to the product range. The new diameter stents incorporate the Misago product line's rapid-exchange delivery system for precise and easy deployment and for a single-operator technique.
The company stated that the Misago stent has been studied in the MISAGO 1 trial, which enrolled 55 patients treated with 83 Misago stents. At 6-month follow-up, the clinical outcomes showed a restenosis rate of 8.5% and a repeat revascularization rate of 3.6%. The results of the ongoing MISAGO 2 study, which enrolled 770 patients in 79 centers, will be presented at the CIRSE 2009 conference to be held September 19 to 23 in Lisbon, Portugal, and at the TCT 2009 conference to be held September 21 to 25 in San Francisco, California.