Sequent Medical said today it won clearance from the FDA to add its smaller .021″ Web aneurysm embolization system to its investigational device exemption trial.
The smaller .021″ version is the latest generation Web device from the Aliso Viejo, Calif.-based company, delivered through a smaller version of its VIA microcatheter. 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.
“Thanks to the efforts of our physician investigators, Web-IT is well underway with 60% of the study enrolled to date. 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,” CEO Tom Wilder said in prepared remarks.
The smaller Web device is designed to improve navigability, and has been used in 250 European patients since May this year, Sequent said. Both the Web system and VIA microcatheter have received CE Mark approval in the European Union.
The 139-patient Web-IT study was launched last August, looking to evaluate 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.