August 27, 2014
IDE Study Begins for Sequent Medical's Web Aneurysm Embolization System
August 28, 2014—Sequent Medical, Inc. announced that it has initiated patient enrollment in the WEB-IT (Web intrasaccular therapy) study. WEB-IT is an investigational device exemption (IDE) pivotal trial to evaluate the safety and effectiveness of Sequent’s Web aneurysm embolization system.
According to the company, the Web consists of a dense mesh constructed from a large number of extremely fine nitinol wires; it functions as an intrasaccular flow disrupter, bridging the neck of the aneurysm and providing rapid, periprocedural stasis.
The prospective, multicenter, single-arm WEB-IT trial is approved to enroll 139 patients at up to 25 sites to evaluate the Web device for the treatment of both ruptured and unruptured intracranial bifurcation aneurysms. The study will include 20 sites in the United States, as well as sites in Canada and Europe.
The WEB-IT study’s principal investigator, Adam Arthur, MD, enrolled the first four patients in the study at Methodist University Hospital in Memphis, Tennessee. Dr. Arthur is Associate Professor at the University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic. David Fiorella, MD, of SUNY Stonybrook in New York, will serve as coprincipal investigator for the study.
In Sequent Medical’s press release, Dr. Arthur commented, “The Web is a revolutionary treatment for challenging ruptured and unruptured aneurysms. 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 United States sites with many sites anticipating patient enrollment over the coming weeks.”
Sequent Medical’s Web aneurysm embolization system and Via microcatheter have both received European CE Mark approval. In the United States, the Web is an investigational device limited by United States law to investigational use. The Via device 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.