Sequent Medical has announced that it has completed patient enrolment in its Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of the WEB Aneurysm Embolisation System.
The WEB Intrasaccular Therapy Study (WEB-IT) enrolled 150 patients at 31 participating sites in the USA, 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 Adam Arthur, professor, University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic and principal investigator of the WEB-IT study. “Completion of enrolment 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 US 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 chief executive officer of Sequent Medical. “Completing enrolment 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 are pleased with our continued progress towards our objective of US regulatory approval.”
The WEB-IT study is a prospective, multicentre, 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.