ALISO VIEJO, California, Feb. 12, 2015 /PRNewswire/ --Sequent Medical announced today that the U.S. Food and Drug Administration has approved the inclusion of the SL ("Single Layer") family of WEB' Aneurysm Embolization Device devices for use in its U.S. Investigational Device Exemption ("IDE") clinical study called WEB-IT. Patient enrollments in WEB-IT have already been completed utilizing the SL family.
Compared to previous versions of the WEB device family, the SL family offers a lower delivery profile, improved navigability, and enhanced visualization. The SL configurations are made possible by further advancement of Sequent Medical's proprietary MicroBraid' technology. The SL family consists of two separate product configurations, the WEB SL and WEB SLS, each with a distinct shape designed to accommodate varying aneurysm morphologies.
"The SL family, which to date has been used to treat over 700 patients globally, represents the latest generation of WEB device," said Sequent President and CEO Tom Wilder. "We are pleased to begin to utilize the SL family in WEB-IT, which is the latest example of our ongoing commitment to build a solid foundation of clinical evidence for the WEB."
"Thanks to the efforts of my fellow physician investigators, WEB-IT is off to a strong start with twenty patients enrolled," said Adam Arthur, MD, Professor, University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic and Principal Investigator of the WEB-IT study. "Having access to the latest generation of WEB devices in WEB-IT will help us further accelerate the enrollment of this important clinical trial."
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 VIAhas 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.
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 intracranial aneurysms with the familiarity of an intrasaccular approach while using established biomaterials. To date, the WEB has been used to treat over 1,300 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 150 patients with ruptured or unruptured wide neck intracranial bifurcation aneurysms. The study will be conducted at 25 investigational sites, including 20 in the United States. More information on the WEB-IT study can be found at www.clinicaltrials.gov under NCT# 02191618.
