Essential Catalog

Product catalog summary

Overview: The document details the features and clinical efficacy of the Paclitaxel-eluting coronary dilation balloon catheter, known as 'essential', developed by iVascular. It highlights the proprietary TransferTech technology that enhances the device's performance.

Drug Coating: The catheter features a multilayer coating that improves mechanical properties, ensuring better adhesion to the balloon and minimizing handling consequences. It provides a homogeneous and precise distribution of paclitaxel, with a concentration of 3µg/mm², ensuring effective treatment of coronary injuries. The microcrystalline structure allows excellent drug transfer to the vessel wall, with fast absorption (30-60 seconds) and high retention time.

TransferTech Technology: This technology optimizes the coating properties and device functionalities, enhancing clinical efficacy. It involves a nanotechnology drop dosage procedure that results in a thin multilayer coating.

Preclinical Efficacy: The essential catheter shows a 28-day restenosis rate statistically lower than the control and up to 23% less than competitors, based on a preclinical study with 17 subjects.

Device Features: The Xperience balloon platform offers a low tip profile for higher crossability and excellent navigability for treating small vessels and bifurcations. It includes a tungsten-based polymeric radiopaque marker for visibility and a balanced design for pushability and flexibility.

Pharmacokinetics: The catheter ensures rapid paclitaxel release with long-term efficacy, maintaining drug availability in the arterial wall over time.

Main Specifications: The catheter has a rapid exchange system, a working length of 142 cm, and is compatible with a maximum guide wire of 0.014”. It operates at a nominal pressure of 6 atm and a rated burst pressure of 16 atm, with a shelf life of 3 years. It includes brachial and femoral markers on the proximal side.

Manufacturing and Distribution: The product is manufactured by LVD Biotech, S.L., and distributed by iVascular, with a CE mark indicating compliance with European standards.

Catalog excerpts

Paclitaxel-eluting coronary dilatation balloon catheter THE CORONARY SOLUTION

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Effectiveness based on propietary technology TransferTech Based on the succesful balloon platform xperience, essential features unprecedented trackability, drug elution rate and effectiveness thanks to the new TransferTech technology from iVascular. TransferTech Nanotechnology drop dosage procedure that yields a multilayer thin coating. Homogeneous and precise paxclitaxel concentration of 3µg/mm². Transfertech has been engineered to improve clinical efficacy by optimizing coating properties and device functionalities. Drug coating TransferTech Clinical Efficacy Drug coating Improved mechanical...

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TransferTech technology provides essential with excellent navigability to treat small vessels, instrastent restenosis and bifurcations of lateral branches. Xperience balloon platform also features: Balanced transition Low tip profile and tip transition (0.016”/0.026”) for a higher crossability. Optimized design for excellent pushability and flexibility. Tungstenbased polymeric Radiopaque Marker Greater flexibility with the same visibility. Preclinical Efficacy Essential yields 28-day restenosis that is statistically lower than the control and goes up to 23% less than competitors. % Area (histological...

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Main Features • Rapid exchange • (Dorking catheter length: 142 cm • Guide wire compatibility: • Rated Burst Pressure (RBP): • Shelf life: 3 years • Braquial and femoral markers Product with CE mark References Working Catheter Length 142 cm

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Essential Catalog

Essential Catalog

Catalog excerpts

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