Sequent Medical has obtained CE Mark approval for the Enhanced Visualization (EV) versions of its WEB aneurysm embolization system and the company has begun a controlled release of these new versions in select European neurovascular centers.
The EV versions incorporate enhanced wire technology and offer improved visualization of the WEB, while preserving desired mechanical properties.
By making the fine Nitinol mesh of the WEB more radiographically visible, the EV will further improve the ease of use.
The EV technology will be incorporated into all three of the existing WEB configurations, including WEB DL, SL and SLS models.
Sequent Medical president and CEO Tom Wilder noted EV technology is the latest demonstration of the company’s robust innovation capability, and further extends its leadership of the intrasaccular flow disruption category.
"In light of the new generation of complex therapeutic devices, we believe the VIA is an important addition to the neurovascular armamentarium here in the US. We intend to explore US commercialization opportunities for the VIA in 2014," Wilder added.
Sequent Medical has also obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the VIA family of microcatheters for intracranial neurovascular use.
Available in two configurations, a 0.027" and 0.033" inner lumen diameter, the VIA microcatheter provides an optimal combination of properties for stable placement, retrieval and navigability of various therapeutic devices.