Paclitaxel releasing hemodialysis shunt balloon dilatation catheter Specifically designed for AVF stenosis Powered by SAFEPAX® Technology The 3rd generation, unique paclitaxel matrix system with the highest coating stability on the market

Aperto® OTW: Paclitaxel releasing hemodialysis shunt balloon dilatation catheter specifically designed for AVF stenosis APERTO® OTW was developed specifically to solve unmet clinical needs in treatment of hemodialysis access stenosis and recanalization of AVF shunt grafts. Variety of shaft and balloon sizes for maximal adaptability to different stenosis situations Up to 20 bar balloon pressure for long-term patency. 40 cm shaft for treatment of native and prosthetic AVF stenosis. Up to 10 mm, 80 cm long shaft to reach and treat central venous stenosi

Aperto® OTW: Clinically confirmed, excellent long-term rates of freedom from restenosis for extended dialysis access survival1 “Thoughtful use of various endovascular techniques can improve access longevity and patients’ quality of life.” 2 Data from 200 patients and 311 angioplasty procedures1 confirm: Single angioplasty procedures have achieved 64% patency rates at 12 months and 41% at 24 months APERTO® OTW is successful with both autogenous and prosthetic vascular access DCB should not be a second option, but first line treatment for all AVF stenosis Prof. Matteo Tozzi APERTO® OTW Italian...

Technical Data Drug releasing balloon Shaft material Balloon material Usable catheter length Rated burst pressure From 12 bar to 20 bar (see table below) Nominal pressure Introducer sheath size Drug coating technology Drug Drug dose Delivery matrix Coated area Cylindrical section of the balloon, exceeding the proximal and distal markers 0.035 PTA balloon Polyamide Distal single lumen hypotube Marker band embedded Hydrophilic coated middle shaft Proximal shaft Polyamide OTW Ordering Information Balloon Ø (mm)

The Paclitaxel Matrix of the Future Powered by SAFEPAX® Technology: The 3rd generation, unique paclitaxel matrix system with the highest coating stability on the market* Powered by Locally delivered 3 μg/mm2 paclitaxel dose for consistent inhibition of neointimal proliferation without compromising safety Virtually loss-less matrix for improved homogeneity of drug transfer Proprietary ammonium salt solution excipient for minimal drug loss during introduction to target site; reliable drug release and transfer into the vessel wall; low surface friction; consistent smoothness and minimised risk of...

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