IDE Granted for New 0.021-Inch Devices in Sequent Medical's WEB-IT Study

October 12, 2015—Sequent Medical announced that the US Food and Drug Administration has approved the inclusion of the company’s Web 0.021-inch devices for use in the WEB-IT (Web intrasaccular therapy) United States investigational device exemption (IDE) clinical study, which began enrollment in August 2014. The 0.021-inch devices are the latest generation of Sequent’s Web aneurysm embolization technology, and are delivered through the Via 21, a downsized version of the company's existing Via microcatheter.

Compared to earlier versions, the 0.021-inch Web devices have a reduced delivery profile to aim to improve navigability. The lower-profile devices include all Web implants up to 7 mm in diameter. Since the initial commercial launch in May 2015, the 0.021-inch devices have been used to treat more than 250 patients in Europe.

David Fiorella, MD, who is the Coprincipal Investigator of the WEB-IT study, and Henry Woo, MD, recently enrolled the first WEB-IT patients treated with the 0.021-inch system at Stoney Brook University Hospital in Stony Brook, New York. In the company’s press release, Dr. Fiorella commented, “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.”

Sequent Medical advised that both the Web aneurysm embolization system and the Via microcatheter have received European CE Mark approval. In the United States, the Via has been cleared for commercial use and the Web is an investigational device limited by United States law to investigational use.