APERTO OTW®

Product catalog summary

Introduction
The document introduces the APERTO® OTW, a paclitaxel-releasing hemodialysis shunt balloon dilatation catheter designed specifically for treating arteriovenous fistula (AVF) stenosis. It is powered by SAFEPAX® technology, which offers a unique paclitaxel matrix system with high coating stability.

Specifications
The catheter is available in various shaft and balloon sizes to adapt to different stenosis situations. It can withstand up to 20 bar balloon pressure for long-term patency and is available in lengths suitable for both native and prosthetic AVF stenosis, as well as central venous stenosis.

Clinical Performance
Clinical data from 200 patients and 311 angioplasty procedures show that single angioplasty procedures with APERTO® OTW achieve 64% patency rates at 12 months and 41% at 24 months. The catheter is effective for both autogenous and prosthetic vascular access, and it is recommended as a first-line treatment for all AVF stenosis.

Technical Data
The catheter features a drug-releasing balloon made of polyamide, with a usable length of 40 cm or 80 cm for larger diameters. It supports a maximum guidewire size of 0.035” and has a rated burst pressure ranging from 12 to 20 bar, depending on the balloon diameter.

Drug Coating Technology
The catheter uses a SAFEPAX® delivery matrix to deliver a 3.0 μg/mm² dose of paclitaxel, ensuring consistent inhibition of neointimal proliferation. The matrix minimizes drug loss during introduction and ensures reliable drug release and transfer into the vessel wall.

Ordering Information
The document provides detailed ordering information, including balloon lengths and diameters, as well as rated burst pressures for different configurations.

Conclusion
The APERTO® OTW catheter, with its advanced SAFEPAX® technology, offers a stable and effective solution for treating AVF stenosis, improving access longevity and patient quality of life.

Catalog excerpts

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

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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

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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...

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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)

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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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International Sales Office and Legal Manufacturer CARDIONOVUM GmbH Am Bonner Bogen 2 53227 Bonn Germany

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