Sequent Medical, Inc. announced today that it has initiated patient enrollment in an Investigational Device Exemption (“IDE”) pivotal trial to evaluate the safety and effectiveness of the WEBTM Aneurysm Embolization System (“WEB”). Adam Arthur, MD, Associate Professor, University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic and Principal Investigator of the WEB-IT study enrolled the first four patients in the study, treating them with the WEB at Methodist University Hospital in Memphis, Tennessee.
The study, WEB Intrasaccular Therapy Study (WEB-IT), is approved to enroll 139 patients at up to 25 sites in the U.S., Canada, and Europe, and will evaluate the WEB for the treatment of both ruptured and unruptured intracranial bifurcation aneurysms.
The WEB consists of a dense mesh constructed from a large number of extremely fine Nitinol wires, and functions as an intrasaccular flow disrupter, bridging the neck of the aneurysm and providing rapid, peri-procedural stasis.
“The WEB is a revolutionary treatment for challenging ruptured and unruptured aneurysms,” stated Dr. Arthur. “The initiation of the WEB-IT study represents an important milestone for this exciting technology platform and a critical step towards improving outcomes in a patient population with significant unmet needs. I look forward to collaborating with a talented group of physician investigators. Study activities are already underway across 20 U.S. sites with many sites anticipating patient enrollment over the coming weeks.” The study will be conducted by a group of experienced North American and European physicians including David Fiorella, MD PhD, SUNY Stonybrook, who will serve as co-Principal Investigator for the study.
“The WEB-IT study is the latest chapter in our ongoing commitment to build a solid foundation of clinical evidence for the WEB, which includes three European prospective, multicenter studies (WEBCAST, French Observatory, and WEBCAST 2), fifteen peer-reviewed clinical publications, and nearly 1,000 patients treated with the WEB,” said Sequent President and CEO Tom Wilder. “At Sequent, we pride ourselves not only on groundbreaking technical innovation, but also on robust scientific evidence.”
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 MicroBraidTM 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. 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. To date, the WEB has been used to treat nearly 1,000 ruptured and unruptured aneurysms in Europe, Turkey, Latin America, Australia and New Zealand.
About The WEB-IT Study
The WEB-IT study is a prospective, multicenter, single-arm study evaluating the WEB in 139 patients with ruptured or unruptured wide neck intracranial bifurcation aneurysms. The study will be conducted at 25 investigational sites, including 20 US sites. More information on the WEB-IT study can be found at www.clinicaltrials.gov under NCT# 02191618.