Sequent Medical Announces Completion of Patient Enrollment in IDE Study for the WEB Aneurysm Embolization System
ALISO VIEJO, California, March 8, 2016 /PRNewswire/ -- Sequent Medical, Inc. a privately held venture backed medical device company dedicated to the development of innovative catheter-based neurovascular technologies, announced today that it has completed patient enrollment in its Investigational Device Exemption ("IDE") pivotal trial to evaluate the safety and effectiveness of the WEB™ Aneurysm Embolization System ("WEB").
The WEB Intrasaccular Therapy Study ("WEB-IT") enrolled 150 patients at 31 participating sites in the U.S., Canada, and Europe. Data from the study will be used to 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 disruptor, bridging the neck of the aneurysm and providing rapid, peri-procedural stasis.
"The WEB is a valuable tool for the treatment of wide-necked bifurcation aneurysms," stated Dr. Adam Arthur, Professor, University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic and Principal Investigator of the WEB-IT study. "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 U.S. patients. We look forward to reporting long-term results."
"The WEB-IT study is the first-ever pivotal study of an intrasaccular flow disruptor," said Tom Wilder, President and CEO of Sequent. "Completing enrollment ahead of schedule represents another major milestone for Sequent. We are highly encouraged by the physician investigators' enthusiasm for the WEB device and commitment to enrolling the study so proficiently and we're pleased with our continued progress towards our objective of U.S. regulatory approval."
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 Medical is headquartered in Aliso Viejo, California, and has European operations based in Bonn, Germany.
About WEB Aneurysm Embolization System
Building upon the foundation of endovascular embolic coils, the WEB device is an intrasaccular flow disruptor that is implanted into a ruptured or unruptured intracranial aneurysm to promote rapid, peri-procedural stasis. The WEB system is based upon Sequent Medical's proprietary MicroBraid™ technology, a dense mesh constructed from a large number of extremely fine wires. Unlike conventional medical braids, 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 system enables physicians to treat a broad range of intracranial aneurysms with the familiarity of an intrasaccular approach while using established biomaterials. To date, the WEB device has been used to treat over 2,500 ruptured and unruptured aneurysms worldwide.
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. More information on the WEB-IT study can be found at www.clinicaltrials.gov under NCT# 02191618.
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