Conformatie Europeene (CE) marking for Interventional Technologies (IVT) cutting balloon:
This article was originally published in Clinica
Interventional Technologies has been awarded CE marking for its cutting balloon catheter, which combines conventional balloon angioplasty (PTCA) with microsurgical blades. Already cleared for the Japanese and Canadian markets, the cutting balloon this year successfully completed global multi-centre, non-randomised studies in over 300 patients, says San Diego-based IVT. Still in progress are a single-centre non-randomised trial in Toyohashi, Japan (400-plus patients), and a Phase III global trial that will randomise 1,244 patients against conventional PTCA. The latter study, which is being carried out in the US, Canada, Belgium, the Netherlands and France, will examine restenosis and target vessel revascularisation rates at six-month follow-ups.