Sequent Medical has announced that the US Food and Drug Administration has approved the inclusion of WEB .021” devices for use in its US 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 7mm 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.
Henry Woo and David Fiorella enrolled the first WEB-IT patient treated with the .021” system recently at Stony Brook University Hospital. Fiorella, 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 chief executive officer, Tom Wilder. “We are pleased to begin to utilise 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.”