Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty.
The Luminor 18 is 0.018 guidewire compatible and has an extra low profile, and joins the company’s Luminor 14 and Luminor 35 portfolio of drug-eluting balloons
“The CE mark approval of Luminor 18 represents a key milestone for iVascular S.L.U. Our extensive range of products will contribute to providing better support and service to patients and physicians,” CEO Lluis Duocastella said in a press release.
The Barcelona, Spain-based company said it is preparing to launch the Luminor 18, which it plans to make available in all of Europe and where CE Mark approval can expedite the registration process.
“The well tapered, perfectly visible LUMINOR18 has an ultra-low profile. It is 4F introducer sheath compatible in most sizes, which is a significant improvement in the Drug Eluting Balloons world,” Dr Koen DeLoose of Dendermonde, Belgium said in a prepared statement.