Vesteck scientific advisory board members along with key opinion leaders from around the world have successfully completed the first three in-human cases with the Suture-Tight catheter, a press release reports.
Dai Yamanouchi (University of Wisconsin, Madison, USA) and Dainis Krievins (Paul Stradins Clinical University Hospital, Riga, Latvia) successfully performed the first two endovascular aneurysm repair (EVAR) procedures utilising the Suture-Tight catheter in Riga, Latvia.
In the first two patients, the Suture-Tight device was used to secure a commercially available EVAR graft to the aorta during the initial implant. Most importantly, Vesteck relays, the devices performed as intended and both patients were discharged from the hospital and home the very next day.
Yamanouchi comments: “In my opinion, the Vesteck device is a game-changer in the endovascular repair of aortic aneurysms. With its ability to secure stent grafts to the aortic wall, it addresses a critical unmet clinical need. This should be particularly important in preventing Type I endoleaks at the initial stent graft implant and treating late Type I endoleaks after EVAR, where the current solutions fall short. I am thrilled to see this innovative technology make its way to their FDA [US Food and Drug Administration] 510K clinical trial and look forward to seeing the resulting data, supporting improved patient outcomes.”
Krievins remarks: “This appears to be a good solution, to have endovascular fixation like a surgical suture. Thus, possibly preventing AAA [abdominal aortic aneurysm] endografts from migration, providing good seal and improving endograft durability in the long term.”
Vesteck’s chief medical consultant, Sean Lyden (Cleveland Clinic, Cleveland, USA) together with Bao Bui (CHUS Hospital Fleurmont Sherbrooke, Sherbrooke, Canada) helped a third aortic aneurysm patient in Montreal, Canada, by quickly and safely securing the endovascular graft to the aorta at the time of initial implant.
“I was very excited to participate in a procedure using this new device for the first time in North America,” said Lyden. “Endovascular specialists are in need of additional tools like this to help our EVAR/TEVAR [thoracic endovascular aortic repair] patients.”
Bui stated after the case: “The Suture-Tight catheter will inevitably change the landscape of EVAR/TEVAR by providing a secure attachment of the endograft to the neck of aortic aneurysms, eliminating long-term neck dilatation, secondary migration and leaks.”
Vesteck CEO, Joe Rafferty asked: “Are you sensing a theme here, with these comments from global endovascular key opinion leaders? The Vesteck Suture-Tight catheter is a much-needed tool, addressing a significant unmet patient need. This is a very exciting milestone. Vesteck has now become a clinical stage company, actively helping aortic aneurysm patients around the world.”