Sequent Medical Announces 1-Year Data and Launches Next-Generation Web Intracranial Aneurysm Embolization System

May 12, 2015—Sequent Medical, Inc. announced that prospective long-term clinical data for the company’s Web aneurysm embolization system were presented by Prof. Laurent Pierot, MD, at the 42nd annual congress of the Société Française de Neuroradiologie (SFNR), which was held April 8–10 in Paris, France.

Sequent also announced the commercial launch of its latest-generation Web device, which features a reduced delivery profile of 0.021 inch and a downsized version of the company’s Via microcatheter.

The Web aneurysm embolization system is an intrasaccular flow disrupter using Sequent Medical’s MicroBraid technology to bridge the neck of a ruptured or unruptured intracranial aneurysm and to promote rapid, periprocedural stasis. The Web system and the Via microcatheter have received European CE Mark approval. In the United States, the Via has been cleared for commercial use, but the Web is limited by United States law to investigational use.

At SFNR, Prof. Pierot reported 12-month data from two separate prospective, multicenter, core lab-reviewed studies, WEBCAST and the French Observatory. Results are preliminary, with full data analysis to be made available later this summer, advised the company.

According to Sequent Medical, the study examined the safety and aneurysm occlusion rates in patients with complex wide-neck bifurcation aneurysms (mean neck size, 5.5 mm) treated with the Web device in 15 European centers. The studies demonstrated 53% complete and 81% adequate occlusion in 96 patients with 1-year imaging. As previously reported, safety results were excellent, with 2.7% procedure-related morbidity and 0% mortality at 30 days.

In the company’s press release, Prof. Pierot commented, “We are pleased to find significant and stable aneurysm occlusion rates out to 1 year even in these difficult-to-treat aneurysms. When coupled with an impressive safety profile, these results are simply outstanding.” Prof. Pierot is Head of the Department of Radiology at Maison Blanche Hospital in Reims, France.

These results from SFNR add to the clinical evidence for the Web, which now includes more than 200 patients enrolled across four prospective, multicenter clinical studies: the WEB-IT investigational device exemption study in the United States and the ongoing European WEBCAST, French Observatory, and WEBCAST 2 studies.  In addition to the prospective studies, there are more than 15 peer-reviewed clinical publications on the Web device composed of more than 1,600 treated patients.

“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,” stated Prof. Pierot.

According to Sequent Medical, the new, smaller system with a lower profile will improve the deliverability of the Web and allow the device to treat a broader range of aneurysms. Initially, the 0.021-inch system will be available for all Web implants up to 7 mm in diameter, which represents a majority of Web cases, noted the company.

In advance of a full market launch, Sequent Medical recently completed a controlled release of the new system in select neurovascular centers that gathered initial physician feedback from more than 40 cases at 10 centers.

Prof. Istvan Szikora, MD, commented, “I used the 0.021-inch system in a series of recent cases, and I have been extremely impressed. The 0.021-inch 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.” Prof. Szikora is Head of the Department of Neurointerventions at the National Institute of Clinical Neurosciences in Budapest, Hungary.