ALISO VIEJO, Calif., Oct. 12, 2015 /PRNewswire/ -- Sequent MedicalTM announced today that the U.S. Food and Drug Administration has approved the inclusion of WEBTM .021" devices for use in its U.S. Investigational Device Exemption (“IDE”) clinical study called WEB-IT. The .021" devices represent the latest generation of WEB technology, and are delivered through a downsized version of the company’s existing VIA® microcatheter, the VIA 21.
Compared to earlier versions, the .021" WEB devices have a reduced delivery profile designed to improve navigability. The lower profile devices include all WEB implants up to 7 mm in diameter, which comprise a majority of cases. Since the initial commercial launch in May 2015, the .021" devices have been used to treat over 250 patients in Europe.
Dr.'s Henry Woo and David Fiorella enrolled the first WEB-IT patient treated with the .021" system recently at Stony Brook University Hospital. Dr. Fiorella, M.D., Ph.D. and co-Principal Investigator for the study remarked, “We immediately noted the improved delivery of the lower profile system. Having access to the latest generation of WEB devices in WEB-IT will help us complete this important clinical trial.”
“Thanks to the efforts of our physician investigators, WEB-IT is well underway with 60% of the study enrolled to date,” said Sequent President and CEO Tom Wilder. “We are pleased to begin to utilize the most current generation of our technology in WEB-IT, the latest example of our ongoing commitment to build a solid foundation of clinical evidence for the WEB.”
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 is headquartered in Aliso Viejo, California, and has European operations based in Bonn, Germany.
About The WEB Aneurysm Embolization System
Building upon the foundation of endovascular embolic coils, the WEB is an intrasaccular flow disrupter designed to bridge the neck of a ruptured or unruptured intracranial aneurysm and to promote rapid, peri-procedural stasis. The WEB is based upon Sequent Medical’s proprietary MicroBraidTM technology, a dense mesh constructed from a large number of extremely fine Nitinol wires. Unlike conventional medical braids, MicroBraid features a mix of wire diameters to achieve a tailored balance of compliance, porosity and profile across device sizes.
The WEB 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 has been used to treat over 2,000 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. The study will be conducted at 30 investigational sites, including 25 in the United States. More information on the WEB-IT study can be found at www.clinicaltrials.gov under NCT# 02191618.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sequent-medical-announces-approval-to-utilize-latest-generation-web-devices-in-us-ide-study-300157073.html
SOURCE Sequent Medical, Inc.
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