Data Support Sequent Medical's Web Aneurysm Embolization System

November 14, 2013—Sequent Medical, Inc. (Aliso Viejo, CA) announced the presentation of long-term results from a retrospective study of the company’s Web aneurysm embolization system at the World Federation of Interventional Neuroradiology Congress in Buenos Aires, Argentina. The data were presented by Professor Laurent Pierot, MD, who is Head of the Department of Radiology at Maison Blanche Hospital in Reims, France.

The study examined mid- and long-term aneurysm occlusion rates in 45 patients treated with the Web system at 12 European centers. In this group of patients with complex wide-neck bifurcation aneurysms, adequate occlusion was achieved in 81.1% of cases at midterm (median, 6 months) and 89.7% of cases at long-term (median, 13 months) follow-up. Good clinical outcomes (modified Rankin scale < 2) were observed in 93.3% of patients at the last follow-up. The treatment was stable over time, with the occlusion status of 92.9% of cases remaining stable or improving between mid- and long-term follow up.

In the company’s press release, Prof. Pierot commented, “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. 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.”

According to Sequent, these 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. WEBCAST is a prospective, multicenter, 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 device, noted the company.

In other news, 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 devices 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 from more than 50 cases at over 15 centers before full market release.

Werner Weber, MD, commented, “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. 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.” Dr. Weber is Head of the Department of Radiology and Interventional Neuroradiology at Klinikum Vest, Knappschaftskrankenhaus in Recklinghausen, Germany.

Sequent Medical’s Web aneurysm embolization system and Via microcatheter have both received European CE Mark approval. They are not approved or available for sale or use in the United States.

The Web is an intrasaccular flow disrupter designed to bridge the neck of a ruptured or unruptured intracranial aneurysm and to promote rapid periprocedural stasis. The Web device is based upon Sequent Medical’s MicroBraid technology, a dense mesh constructed from a large number of extremely fine nitinol wires. MicroBraid features a mix of wire diameters to achieve a tailored balance of compliance, porosity, and profile across device sizes.

The Web treats 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.