Sequent Medical initiates patient enrollment in IDE pivotal trial of WEB Aneurysm Embolization System

Aug 28 2014

Sequent Medical, Inc. announced today that it has initiated patient enrollment in an Investigational Device Exemption ("IDE") pivotal trial to evaluate the safety and effectiveness of the WEB™ Aneurysm Embolization System ("WEB"). Adam Arthur, MD, Associate Professor, University of Tennessee Department of Neurosurgery/Semmes-Murphey Clinic and Principal Investigator of the WEB-IT study enrolled the first four patients in the study, treating them with the WEB at Methodist University Hospital in Memphis, Tennessee.

The study, WEB Intrasaccular Therapy Study (WEB-IT), is approved to enroll 139 patients at up to 25 sites in the U.S., Canada, and Europe, and will 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 disrupter, bridging the neck of the aneurysm and providing rapid, peri-procedural stasis.

"The WEB is a revolutionary treatment for challenging ruptured and unruptured aneurysms," stated Dr. Arthur. "The initiation of the WEB-IT study represents an important milestone for this exciting technology platform and a critical step towards improving outcomes in a patient population with significant unmet needs. I look forward to collaborating with a talented group of physician investigators. Study activities are already underway across 20 U.S. sites with many sites anticipating patient enrollment over the coming weeks." The study will be conducted by a group of experienced North American and European physicians including David Fiorella, MD PhD, SUNY Stonybrook, who will serve as co-Principal Investigator for the study.

"The WEB-IT study is the latest chapter in our ongoing commitment to build a solid foundation of clinical evidence for the WEB, which includes three European prospective, multicenter studies (WEBCAST, French Observatory, and WEBCAST 2), fifteen peer-reviewed clinical publications, and nearly 1,000 patients treated with the WEB," said Sequent President and CEO Tom Wilder. "At Sequent, we pride ourselves not only on groundbreaking technical innovation, but also on robust scientific evidence."