Sequent Medical's WEBCAST Study Presented at ESMINT

September 8, 2014—Sequent Medical, Inc. announced the presentation of results from WEBCAST, a prospective study of the company’s Web aneurysm embolization system, at ESMINT, the European Society of Minimally Invasive Neurological Therapy Congress in Nice, France. The data were presented at ESMINT by Prof. Laurent Pierot, MD, who is head of the Department of Radiology at Maison Blanche Hospital in Reims, France.

According to Sequent Medical, the study examined safety and aneurysm occlusion rates in 51 patients with complex wide-neck bifurcation aneurysms treated with the Web device at 10 European centers. The study met the primary efficacy endpoint, demonstrating 85.4% adequate and stable occlusion without retreatment at 6-month follow-up. The study also demonstrated the device’s safety at 30 days and 6 months, with 0% procedure-related morbidity and mortality.

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

Prof. Pierot added, “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.”

Sequent Medical advised that in the United States, the Web is an investigational device limited by law to investigational use. The Web aneurysm embolization system and Via microcatheter have both received European CE Mark approval. The Via has been cleared for commercial use in the United States.

According to Sequent Medical, the Web intrasaccular flow disrupter builds upon the foundation of endovascular embolic coils. It is designed to bridge the neck of a ruptured or unruptured intracranial aneurysm and to promote rapid, periprocedural stasis. The Web 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 company stated that 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. The Web has been used to treat ruptured and unruptured aneurysms in patients in Europe, Turkey, Latin America, Australia, and New Zealand.

The WEBCAST 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); 15 peer-reviewed clinical publications; and approximately 1,000 patients treated with the Web, noted the company.