Sequent Medica has announced the presentation of prospective long-term clinical data for the WEB aneurysm embolisation system at the Societe Francaise de Neuroradiologie (SFNR) meeting (8–10 April, Paris, France). Twelve-month data were reported from two separate prospective, multicentre, core lab reviewed studies called WEBCAST and the French Observatory. Results are preliminary, with full data analysis to be made available later this summer.
Safety and aneurysm occlusion rates were examined in patients with complex wide neck bifurcation aneurysms (mean neck size: 5.5mm) treated with the WEB in 15 European centres. The studies demonstrated 53% complete and 81% adequate occlusion in 96 patients with one-year imaging. As previously reported, safety results were excellent, with 2.7% procedure-related morbidity and 0% mortality at 30 days.
“We are pleased to find significant and stable aneurysm occlusion rates out to one year even in these difficult to treat aneurysms. When coupled with an impressive safety profile, these results are simply outstanding,” said Laurent Pierot, Head of the Department of Radiology, Maison Blanche Hospital, Reims, France, who presented the data at the SFNR meeting.
Clinical evidence for the WEB now includes over 200 patients enrolled across four separate prospective, multicentre clinical studies. These studies are the WEB-IT investigational device exemption study in the USA and three ongoing European studies (WEBCAST, French Observatory, and WEBCAST 2). In addition to the prospective studies, there are now over 15 peer-reviewed clinical publications on the WEB and over 1,600 patients treated. “Given this level of evidence, the WEB is an increasingly well-established therapy with an important and growing role in the management of intracranial aneurysms,” said Pierot.
Sequent also announced the commercial launch of its latest WEB product, which features a reduction in delivery profile of the WEB down to .021 inches. The .021” system also includes a downsized version of the company’s existing VIA microcatheter. The lower profile of the new system “will improve the deliverability of the WEB, and is designed to enable physicians to treat an even broader range of aneurysms with the WEB”, according to a company press release.
The company recently completed a controlled release of the new system in select neurovascular centres that gathered initial physician feedback prior to full market release. “I used the .021” system in a series of recent cases and I have been extremely impressed,” said Istvan Szikora, Head of the Department of Neurointerventions, National Institute of Clinical Neurosciences, Budapest, Hungary. “The .021” system represents a major advance for the WEB platform with the potential to significantly increase the number of aneurysms that I can treat with this technology.”
Initially, the .021” system will be available for all WEB implants up to 7mm in diameter, which represents a majority of WEB cases. “The .021” system is a breakthrough that positions us well for further adoption and growth, particularly in the ruptured segment of the aneurysm market, and we are very optimistic about the significant role the WEB can play in the treatment of intracranial aneurysms,” said Sequent president and chief executive officer Tom Wilder.