Vesteck’s Suture-Tight Catheter for EVAR Used in First-in-Human Procedures

March 20, 2023—Vesteck, Inc. recently announced that the first-in-human procedures were successfully completed with the company’s Suture-Tight catheter.

Dai Yamanouchi, MD, and Professor Dainis Krievins, MD, performed the first two endovascular aneurysm repair (EVAR) procedures with the Suture-Tight catheter in Riga, Latvia. The Suture-Tight device was used to secure a commercially available EVAR graft to the aorta during the initial implant. The devices performed as intended and both patients were discharged from the hospital and home the next day, noted the company.

The third EVAR procedure with the Smart-Tight device was performed by Sean Lyden, MD, and Bao Bui, MD, in Montreal, Canada. The interventionalists quickly and safely secured the endovascular graft to the aorta at the time of the initial implant.

Vesteck, based in West Chester, Pennsylvania, is a clinical-stage medical device company focused on technology for EVAR of abdominal aortic aneurysms (AAAs) and thoracic endovascular aortic repair (TEVAR) as well as structural heart treatments.

Suture-Tight, which is the company’s first product, is a nitinol suture delivery catheter for EVAR that can be used in the initial implant or during repair procedures. The device is not commercially available in the United States or outside the United States.

Vesteck is raising a $16 million Series B round to support a 100-patient clinical trial for FDA 510(k) clearance of the Suture-Tight, advised the company

“In my opinion, the Vesteck device is a game changer in the endovascular repair of aortic aneurysms,” commented Dr. Yamanouchi in Vesteck’s press release.

Dr. Yamanouchi, who is Associate Professor at the University of Wisconsin School of Medicine in Madison, Wisconsin, continued, “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’m thrilled to see this innovative technology make its way to their FDA 510(k) clinical trial and look forward to seeing the resulting data, supporting improved patient outcomes.”

Prof. Krievins, who is from the University of Latvia and Riga Stradins University in Riga, Latvia, added, “This appears to be a good solution to have endovascular fixation like a surgical suture. Thus, possibly preventing AAA endografts from migration, providing good seal, and improving endograft durability in the long term."

Dr. Lyden, who is Chair of Vascular Surgery at the Cleveland Clinic in Cleveland, Ohio, and serves as Vesteck’s chief medical consultant, stated in the press release, “I was very excited to participate in a procedure using this new device for the first time in North America. Endovascular specialists are in need of additional tools like this to help our EVAR/TEVAR patients.”

Dr. Bui, who is an interventional radiologist specializing in endovascular repair at CHUS Hospital Fleurmont Sherbrooke in Quebec, Canada, commented, “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.”