- ALISO VIEJO, California, May 12, 2015 /PRNewswire/ -- Sequent Medical, Inc. announced today the presentation of prospective long-term clinical data for the WEB™ Aneurysm Embolization System at the recent Societe Francaise de Neuroradiologie ("SFNR") meeting in Paris, France. Twelve-month data were reported from two separate prospective, multi-center, 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: 5.5 mm) treated with the WEB in 15 European centers. 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 Prof Laurent Pierot MD PhD, Head of the Department of Radiology, Maison Blanche Hospital, Reims, France, who presented the data at the SFNR meeting.
These results add to a steadily increasing body of clinical evidence for the WEB which now includes over 200 patients enrolled across four separate prospective, multi-center clinical studies. These studies are the WEB-IT Investigational Device Exemption study in the United States 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 Prof. Pierot.
In other news, Sequent announced the commercial launch of its latest generation WEB product, which features a further 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.
The company recently completed a controlled release of the new system in select neurovascular centers that gathered initial physician feedback prior to full market release. The feedback from over 40 cases across 10 centers was outstanding. "I used the .021" system in a series of recent cases and I have been extremely impressed," said Prof Istvan Szikora MD, 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 7 mm 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 CEO Tom Wilder. "Building on our demonstrated expertise with innovative braided devices, we also have several active development projects underway focused on offering an expanded portfolio of products to neurovascular specialists and their patients."
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. To date, the WEB has been used to treat over 1,600 ruptured and unruptured aneurysms worldwide.