LEGFLOW® RX/OTW
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Paclitaxel Releasing Peripheral Balloon Dilatation Catheter ® Powered by SAFEPAX Technology: The 3rd generation, unique paclitaxel matrix system with the highest coating stability on the market Excellent Deliverability: The elastic coating ensures smooth and easy crossing of complex anatomies and the optimised PTA hypotube shaft secures kink resistance and pushability Unsurpassed range of paclitaxel releasing peripheral balloon dilatation catheters

the Paclitaxel Matrix of the Future With SAFEPAX® CARDIONOVUM is leading the way in matrix technology. SAFEPAX® is a third-generation paclitaxel balloon matrix coating, developed exclusively for the CARDIONOVUM family of DCBs for maximal safety and optimised drug delivery. 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 - Hydrophobic during catheter tracking Minimal drug loss during introduction to...

Consistent, predictable drug delivery to target lesions, with the lowest paclitaxel wash-off rates of currently available DCBs, as demonstrated in independent tests* There have been no safety issues in LEGFLOW® clinical trials and registries to date (2018). Mohamad Hamady, London UK: “The virtual lack of drug leakage with Legflow is a very promising development. It would be exciting to investigate reduced need for predilation in BTK with this DCB.” Particle size and wash-off rates matter! Studies in non-SAFEPAX® DCBs show: Paclitaxel can leak into the systemic circulation after lower limb...

LEGFLOW® RX/OTW: Reliable Complex Lesion Crossing with all Benefits from SAFEPAX® Matrix LEGFLOW® was developed to facilitate complex lesion crossing and deliver the advantages of the third-generation virtually loss-less SAFEPAX® matrix. The catheter design combined with the high elasticity of the SAFEPAX® matrix ensures low stickness, kink resistance and smooth pushability. Guidewire friction is further reduced by an extruded guidewire lumen and an atraumatic tip. The PTA balloon was specifically designed for maximal synergy with the unique SAFEPAX® matrix. : Unsurpassed ease of handling...

LEGFLOW® RX/OTW Portfolio: Performance without Compromise CARDIONOVUM offers an unsurpassed range of DCBs for the widest application: - Balloons 2-10 mm diameter; lengths 20-200 mm - Balloons in RX and OTW configuration - LEGFLOW® OTW in three platforms: 014”, 018”, 035” - Introducer sheaths down to 4Fr (Ø 2.0-4.0 mm) The range guarantees physicians the widest choice to ensure that patients benefit from SAFEPAX® technology without compromise. LEGFLOW® RX/OTW is indicated for the treatment of: - Critical limb ischaemia (CLI) - De-novo and restenotic lesions of the SFA - Popliteal artery...

Clinical Program On-going clinical trials are expanding the evidence base in support of the safety and effectiveness of LEGFLOW® in various conditions of real life treatment: - RAPID: long (>15 cm) and intermediate (5-15 cm) lesions MAGNIFICENT: absence of binary restenosis REFLOW: femopopliteal long lesions >15cm LEGFLOW JAPAN: Patients with CLI and de-novo stenosis or embolisation in arteries below the popliteal artery LEG-DEB: Infrainguinal arterial disease in real-world patients (including claudication and CLI) COMPARE: Head-to-head comparison of LEGFLOW® vs. DCB in real-world SFA...

Technical Summaries Ordering Information and Technical Data Usable catheter length 80 cm Usable Balloon Balloon Introducer RBP catheter Ø (mm) length sheath length 135 cm (mm) size (F) Usable catheter length 150 cm Introducer sheath size (F) Usable cathet length

LEGFLOW OTW 0.014 LEGFLOW OTW 0.014 Usable Usable catheter catheter length 150 cm length 150 cm Balloon Balloon Balloon ØØ Balloon (mm) (mm) length length (mm) (mm) Introducer Introducer sheath sheath size (F) size (F) Usable Usable catheter catheter length 140 cm length 140 cm Balloon Balloon Balloon ØØ Balloon (mm) length (mm) length (mm) (mm) Introducer RBP Introducer RBP sheath sheath size (F) size (F) International Sales Office and Legal Manufacturer CARDIONOVUM GmbH Am Bonner Bogen 2 53227 Bonn Germany 1. P. Freyhardt et al., ROFO. Fortschr. Geb. Rontgenstr. Nuklearmed. 183, 448–455...