Sequent Medical Announces Completion of Patient Enrollment in IDE Study for the WEB Aneurysm Embolization System

ALISO VIEJO, Calif.,  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^TM 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."

Source: Sequent Medical, Inc.