Enrollment Completed in WEB-IT Study for Sequent Medical's Aneurysm Embolization System

March 8, 2016—Sequent Medical, Inc. announced today that it has completed patient enrollment in its investigational device exemption pivotal trial to evaluate the safety and effectiveness of the Web aneurysm embolization system.

The Web Intrasaccular Therapy (WEB-IT) study enrolled 150 patients at 31 participating sites in the United States, Canada, and Europe. Data from the study will be used to evaluate the Web device for the treatment of both ruptured and unruptured intracranial bifurcation aneurysms.

Adam Arthur, MD, who is a professor at the University of Tennessee, in the Department of Neurosurgery/Semmes-Murphey Clinic in Memphis, Tennessee, serves as Principal Investigator of the WEB-IT study.

In the company’s press release, Dr. Arthur commented, “The Web is a valuable tool for the treatment of wide-necked bifurcation aneurysms. Completion of enrollment is the result of strong collaboration between a talented group of physician investigators. Their dedication and expertise means we are a step closer to making this treatment available to United States patients. We look forward to reporting long-term results.”

According to the company, the Web device consists of Sequent Medical’s MicroBraid technology, a dense mesh constructed from a large number of extremely fine nitinol wires. MicroBraid allows for a mix of wire diameters or materials to achieve a tailored balance of compliance, porosity, and profile across device sizes.

The Web functions as an intrasaccular flow disruptor, bridging the neck of the aneurysm and providing rapid, periprocedural stasis. With the Web system, physicians can treat a broad range of intracranial aneurysms with the familiarity of an intrasaccular approach while using established biomaterials. The Web aneurysm embolization system has received European CE Mark approval. In the United States, the Web is an investigational device limited by federal law to investigational use, advised Sequent Medical.