FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

iVascular’s Microcatheter Gains CE Mark

Feb. 25, 2019
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iVascular’s Navitian coronary microcatheter received a CE Mark for supporting and handling a guidewire during the treatment of chronic total occlusions (CTOs).

The device is cleared to help navigate guidewires in the case of a near-to-complete blockage of a coronal artery. It is also approved to exchange guidewires and inject radiopaque contrast media or saline solutions.

The microcatheter’s braided pattern improves its flexibility and resistance to kinking, and its hydrophilic coating allows for high trackability in small, complex arteries.

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