iVascular Receives CE Mark Approval for LUMINOR 18 Drug Eluting Balloon

iVascular S.L.U., is pleased to announce that the LUMINOR 18 Drug Eluting Balloon, has received CE (Conformité Européenne) Mark approval.

LUMINOR 18, which is 0.018 Guide Wire compatible, is added to the existing LUMINOR range (Luminor14 and Luminor35), to offer the only complete drug eluting balloon portfolio to physicians performing lower limb angioplasty. Combining extra low profile with effective proven drug eluting coating technology, it will contribute to procedure cost reduction.

Mr. Lluis Duocastella, CEO of iVascular S.L.U., commented, “ The CE mark approval of LUMINOR18 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.”

As stated by Dr Koen DELOOSE (Dendermonde, Belgium), “
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.”

With this CE Mark approval, iVascular S.L.U. is preparing LUMINOR 18 to be commercially available in all Europe and other markets where CE Mark approval can expedite the registration process.

iVascular is a fast growing company based in Barcelona that has developed exclusive technologies in a vertically integrated project to innovate and produce coronary and endovascular devices from basic raw materials to the final device or implant, including DCB, DES, SE nitinol stents, CoCr BMS, thrombus extractors and angioplasty balloons.

Source: iVascular S.L.U.