ALISO VIEJO, Calif. -- Sequent Medical, Inc. announced today that it has received CE mark for the Enhanced Visualization ("EV") versions of the WEB(TM) Aneurysm Embolization System, and has commenced a controlled release of these new versions in select neurovascular centers in Europe.
By incorporating enhanced wire technology, the EV versions will offer improved visualization of the WEB, while preserving desired mechanical properties. EV will further improve the ease of use by making the fine Nitinol mesh of the WEB more radiographically visible. EV technology will be incorporated into all three of the existing WEB configurations: the WEB DL, SL and SLS models.
This latest version of the WEB builds upon the growing experience with the WEB platform that has now been used to treat nearly 600 ruptured and unruptured aneurysms in Europe and Latin America.
"By developing the EV technology, Sequent Medical has further enhanced the capabilities of the WEB system," said Prof Ansgar Berlis, MD, Neuroradiology Department Head, Klinikum Augsburg, Augsburg, Germany, "When combined with the growing body of clinical experience and data on the WEB, the significantly improved angiographic visibility will further accelerate the adoption of the WEB system."
"EV technology is the latest demonstration of Sequent's robust innovation capability, and further extends our leadership of the intrasaccular flow disruption category," said Tom Wilder, President and Chief Executive Officer.
In other news, today Sequent also announced FDA 510k clearance for the VIA(TM) family of microcatheters for intracranial neurovascular use. The VIA microcatheter provides an optimal combination of properties for stable placement, retrieval and navigability of various therapeutic devices. The VIA microcatheter is available in two configurations, a 0.027" and 0.033" inner lumen diameter.
"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," said Tom Wilder. "We intend to explore US commercialization opportunities for the VIA in 2014."
About Sequent Medical, Inc.
Founded in 2007, Sequent Medical, Inc. (www.sequentmedical.com) is a privately held venture backed medical device company that is dedicated to the development of innovative catheter-based neurovascular technologies. The WEB Aneurysm Embolization System has received the CE mark but is not approved or available for sale or use in the United States. Sequent Medical, Inc. is headquartered in Aliso Viejo, California, and has European operations based in Bonn, Germany.
About The WEB Aneurysm Embolization System
Building upon the foundation of endovascular embolic coils, the WEB is an intrasaccular flow disrupter designed to bridge the neck of a ruptured or unruptured intracranial aneurysm and to promote rapid, peri-procedural stasis. The WEB is based upon Sequent Medical's proprietary MicroBraid(TM) technology, a dense mesh constructed from a large number of extremely fine Nitinol wires. Unlike conventional medical braids, MicroBraid features a mix of wire diameters to achieve a tailored balance of compliance, porosity and profile across device sizes.
The WEB enables physicians to treat a broad range of intracranial aneurysms with the familiarity of an intrasaccular approach while using established biomaterials. The WEB product portfolio consists of the WEB DL, SL and SLS configurations. To date, the WEB has been used to treat a wide variety of nearly 600 ruptured and unruptured aneurysms in Europe and Latin America.
CONTACT: Thomas Wilder, President & CEO, Ph. +1-949-830-9600, Fx. +1-949-830-9658
Web Site: http://www.sequentmedical.com