Acandis gets CE mark approval for Derivo embolisation device


The Derivo device is intended for the treatment of patients with intracranial aneurysms that cannot be treated with current endovascular techniques or for patients who would have a high treatment risk with other endovascular or neurosurgical techniques. 

The Derivo embolisation device is suitable for vessels with 3–6mm diameters and is available with two transportwire versions: with a tip, if additional distal support is needed and without a tip if the anatomical situation requires more flexibility. The product is also available as a system which includes a microcatheter for the delivery of the device.

Johannes Flaschka, managing director of Acandis said: “Acandis is using the latest technologies and has implemented highly accurate development processes to ensure a smooth, reliable and precise treatment of intracranial aneurysms with the Derivo embolisation device.”

A press release from Acandis states that the nitinol braiding design supports good vessel wall conformability, even in variable vessel diameters and in very tortuous anatomies. The innovative Acandis proprietary BlueXide Surface Finishing Technology ensures less friction during delivery through the microcatheter as well as a true self-expanding deployment, making the opening of the device smooth and reliable. This finishing contributes to better corrosion resistance which might lead to lower thrombogenicity, the release notes. The device is equipped with a nitinol transport wire to meet the demands of a reliable and effective procedure. The device can be safely recaptured and repositioned if an adjustment and superior placement is needed.

Acandis will be conducting a post market surveillance study, collecting clinical data on the “real life” application of the Derivo embolisation device with regard to long-term success rates and safety aspects. Flaschka said: “Special emphasis is laid on safety aspects as well as the long-term behaviour of the implant within the parent vessel, particularly occurrence and, if applicable, rate of thrombosis.”

The company plans to launch the product in Europe and other countries accepting CE mark approval during the first quarter of 2014.