Prospective Clinical Data On Web Aneurysm Embolization System Demonstrate Excellent Safety And High Rate Of Stable Occlusion In Difficult To Treat Aneurysms
ALISO VIEJO, Calif. and NICE, France, Sept. 8, 2014 /PRNewswire/ -- Sequent Medical, Inc. announced today the presentation of results from WEBCAST, a prospective study of the WEB™ Aneurysm Embolization System at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress.
The study examined safety and aneurysm occlusion rates in 51 patients with complex wide neck bifurcation aneurysms treated with the WEB across 10 European centers. The study met the primary efficacy endpoint demonstrating 85.4% adequate and stable occlusion without retreatment at 6 months follow-up. The study also demonstrated good safety at 30 days and 6 months, with 0% procedure-related morbidity and mortality.
"We are pleased to find significant and stable aneurysm occlusion rates coupled with an excellent safety profile with the WEB even in these difficult to treat aneurysms. These clinical outcomes compare favorably with outcomes of other neurovascular techniques, particularly coiling. These results are even more impressive when considering this patient series comprises cases completed during the early learning curve with the WEB," said Prof Laurent Pierot, MD PhD, Head of the Department of Radiology, Maison Blanche Hospital, Reims, France, who presented the data at the ESMINT meeting. "These results indicate that flow disruption with the WEB will play an increasing role in the management of intracranial aneurysms, especially considering that ruptured aneurysms can also be treated with this technique."
These encouraging results add to a growing body of clinical evidence for the WEB including the recently initiated WEB-IT Investigational Device Exemption study in the United States, two ongoing European prospective, multicenter studies (French Observatory, and WEBCAST 2), fifteen peer-reviewed clinical publications, and nearly 1,000 patients treated with the WEB.
"We are very pleased with the strong results from WEBCAST and look forward to continuing to gather additional clinical evidence on the WEB," said Tom Wilder, President and Chief Executive Officer. "The clinical outcomes shown in WEBCAST provide us with strong momentum as we continue our planned expansion of the WEB franchise."
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 and VIA® Microcatheter have both received the CE mark. The VIA has been cleared for commercial use in the United States. In the United States the WEB is an investigational device limited by United States law to investigational use. Sequent 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™ 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 original WEB DL configuration, the second generation WEB SL and SLS configurations, and the recently introduced Enhanced Visualization (or EV) versions. To date, the WEB has been used to treat nearly 1,000 ruptured and unruptured aneurysms in Europe, Turkey, Latin America, Australia and New Zealand.
SOURCE Sequent Medical, Inc.
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