Medtech company Sequent Medical enrolled the 1st 4 patients in a new U.S. clinical trial aimed at winning FDA approval for its Web aneurysm protection implant.
The Web implant is made of a Nitinol mesh that is delivered in a "stent-like" manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. The device already has approve in the European Union.
The new Web Intrasaccular Therapy Study (WEB-IT) will enroll up to 139 patients at 25 sites in the U.S., Canada and Europe, evaluating the implant for use in both ruptured and un-ruptured aneurysms.
The trial in funded in large part with proceeds from the company’s $20 million Series D funding round that closed in April.