![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » DISA Vascular's Small-Vessel Heart Stent Receives European Approval
DISA Vascular's Small-Vessel Heart Stent Receives European Approval
February 18, 2005
Medical device company DISA Vascular has announced European CE Mark approval and market launch of its ChromoFlex Micro stent system for small coronary vessels, following CE approval of the large-vessel version, the ChromoFlex, in September 2004.
Similar to the large-vessel ChromoFlex, the new Micro version has ultra thin struts. This feature has been shown to reduce restenosis dramatically in independent clinical studies. This is made possible by the use of a special cobalt chromium alloy offering numerous advantages over the more conventional stainless steel because of its increased strength and radiographic visibility.
According to DISA, the new Micro stent, for vessels 2.5 mm to 3 mm in diameter, will have even better deliverability features than the large vessel version because of its extremely low profile and high flexibility.
The ChromoFlex range is marketed as a competitive treatment alternative to drug-eluting stents to reduce restenosis.
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
21Oct