Post Market Clinical Follow-up Study of the DERIVO® Embolisation Device

A new concept for the endovascular treatment of intracranial aneurysms is the implantation of stents that guide the blood flow away from the diseased vessel part. So called „endoluminal embolisation devices“ or „flow diverters“ have a compact mesh system and lead in the long term to a closure of the aneurysm by reconstruction of the original vessel wall and the change of haemodynamic conditions inside the aneurysm.
Flow diverters are well suited for the therapy of complex aneurysms like wide-neck, fusiform or giant aneurysms which cannot be treated with other endovascular techniques.

As this treatment method has existed only for the past few years, it is important to gather and evaluate clinical data in the routine use in order to prove the safety and efficiency of this method in the clinical use.

Within the trial "Post Market Clinical Follow-up of the DERIVO® Embolisation Device" the treatment of intracranial aneurysms will be assessed. The treatment with this flow diverter will be performed within the intended use of the device and represents the clinical treatment routine.

The study objective is to examine the safety and efficacy of aneurysm treatment with the DERIVO® flow diverter with respect to the mid- and long-term clinical and angiographic outcomes. The inclusion of 100 patients to this prospective, multicentre study is foreseen.

Further information about the DERIVO® study can be found here.