Long Term Follow Up Data On WEB Aneurysm Embolization System Demonstrate High Rate Of Stable Occlusion In Difficult To Treat Aneurysms
14 Nov, 2013, 08:00 ET
ALISO VIEJO, Calif., and BUENOS AIRES, Argentina, Nov. 14, 2013 /PRNewswire/ -- Sequent Medical, Inc. announced today the presentation of long-term results from a retrospective study of the WEB™ Aneurysm Embolization System at the World Federation of Interventional Neuroradiology (WFITN) Congress.
The study examined mid- and long-term aneurysm occlusion rates in 45 patients treated with the WEB across 12 European centers. In this group of patients with complex wide neck bifurcation aneurysms, adequate occlusion was obtained in 81.1% of cases in the mid-term (median six months) and 89.7% of cases in the long-term (median 13 months). Good clinical outcome (mRS<2) was observed in 93.3% of patients at the last follow-up. The treatment was quite stable over time, with the occlusion status of 92.9% of cases remaining stable or improving between the mid- and long-term follow up.
"We are pleased to find significant and stable aneurysm occlusion rates with the WEB even in these difficult to treat aneurysms. This excellent long-term clinical outcome compares 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 WFITN 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 six peer-reviewed publications. Building on this foundation, enrollment will be completed late this year in the WEBCAST study, a prospective multi-center European study of 50 patients with ruptured or unruptured wide neck bifurcation aneurysms. Results from this study will provide further evidence regarding the safety and clinical utility of the WEB.
In other news, today Sequent also announced the transition to full market release in Europe for the SL ("Single Layer") family of WEB devices. The SL family consists of two separate product configurations, the WEB SL and WEB SLS, each with a distinct shape. The SL family offers a lower profile and superior navigability that are designed to enable physicians to treat a broader range of aneurysms with the WEB platform. The company recently completed a controlled release in select neurovascular centers that gathered initial physician feedback on the SL family prior to full market release. The feedback from over 50 cases at over 15 centers was excellent.
"After having had the opportunity to use the SL family in a series of recent cases, I was pleased with the improved navigability and performance of these new WEB models," said PD Dr. med. Werner Weber, Head of the Department of Radiology and Interventional Neuroradiology, Klinikum Vest, Knappschaftskrankenhaus, Recklinghausen, Germany. "These new configurations will undoubtedly expand the range of aneurysms physicians can treat with the WEB while continuing to offer the familiar straightforward procedure we've come to value with the WEB DL."
"We are pleased with the results of both the retrospective study and the recent experience with the new SL family. We will continue to invest in prospective clinical studies such as WEBCAST to gather additional clinical evidence on the WEB," said Tom Wilder, President and Chief Executive Officer. "These developments 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. They are 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™ 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 and the recently launched WEB SL and WEB SLS offerings. To date, the WEB has been used to treat a wide variety of nearly 450 ruptured and unruptured aneurysms in Europe, Turkey, Latin America and New Zealand.
SOURCE Sequent Medical, Inc.
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