Sequent Medical has gained U.S. FDA approval to include 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.
Sequent Medical’s 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. It is based on the company’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.
Sequent says the WEB enables physicians to treat intracranial aneurysms with the familiarity of an intrasaccular approach while using established biomaterials.
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 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.
“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.”
Source: Sequent Medical, Inc.
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