VESTECK, Inc. is pleased to announce the first in human use of several SUTURE-TIGHT devices
09 Mar 2023
WEST CHESTER, Pa., March 9, 2023 /PRNewswire/ -- VESTECK, Inc. Scientific Advisory Board members along with Key Opinion Leaders from around the world, successfully completed the first 3 in human cases with the "SUTURE-TIGHT"TM catheter.
Dr. Dai Yamanouchi and Professor Dainis Krievins successfully performed the first two endovascular aortic aneurysm repair (EVAR) procedures utilizing the "SUTURE-TIGHT"TM catheter in Riga, Latvia.
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VESTECK SUCCESFULLY COMPLETES FIRST 3 HUMAN CASES
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In the first two patients, the "SUTURE-TIGHT"TM device was used to secure a commercially available EVAR graft to the aorta during the initial implant. Most importantly, the devices performed as intended and both patients were discharged from the hospital and home the very next day.
Dr. Dai Yamanouchi, Associate Professor at the Univ. of Wisconsin School of Medicine says, "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'm thrilled to see this innovative technology make its way to their FDA 510K clinical trial and look forward to seeing the resulting data, supporting improved patient outcomes."
Professor Krievins from the University of Latvia and Stradins University hospital commented, "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."
VESTECKs Chief Medical Consultant, Dr. Sean Lyden together with Dr. Bao Bui 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 Sean Lyden, MD, Chair of Vascular Surgery at Cleveland Clinic. "Endovascular specialists are in need of additional tools like this to help our EVAR/TEVAR patients."
Dr. Bao Bui, an Interventional Radiologist specializing in endovascular repair at CHUS Hospital Fleurmont Sherbrooke, Quebec stated after the case, "the SUTURE-TIGHT"TM 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-TIGHTTM 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."
VESTECK
About Vesteck Inc.
VESTECK, Inc. (WWW.VESTECK.com) is now a clinical stage medical device company focused on bringing a proprietary technology to the aortic repair and structural heart markets. The first product, the "SUTURE-TIGHTTM" nitinol suture delivery catheter will bring a simple, easy to use technology to the endovascular aortic repair market, solving a significant global challenge. The "SUTURE-TIGHT"TM catheter can be used in the initial implant or during repair procedures.
VESTECK is raising a $16M Series B round to support a 100-patient clinical trial for FDA 510K clearance.
The VESTECK, Inc. "SUTURE-TIGHT"TM is not commercially available in the USA or OUS.
MEDIA CONTACTS: VESTECK, Inc. CEO, Joe Rafferty, [email protected] 610-457-7324
Please note that this document reflects statements that may constitute forward-looking statements and projections that are subject to risks and uncertainties, including information about possible or assumed future events, results of economic conditions and VESTECK's business, results of operations, plans and objectives. These statements are based on management's beliefs, assumptions and expectations of VESTECK's future performance, taking into account information currently available to it. You should not place undue reliance on such statements, as new risks and uncertainties may arise and it is not possible for management to predict those events or how they may affect VESTECK, Inc.
SOURCE VESTECK, Inc.
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