Gore has announced the US launch of the lower profile, large diameter Gore Viabahn endoprosthesis.
Gore previously received approval from the US Food and Drug Administration (FDA) for the enhanced Gore Viabahn endoprosthesis.
“With broad clinical indications for use and numerous product improvements, the Viabahn device continues to be a dependable choice that demonstrates positive results in patients with complex vascular disease,” comments Amit J Dwivedi, (University of Louisville, Louisville, USA), who has implanted the lower profile device in complex arterial anatomy. “Older patients with co-morbidities such as hypertension, diabetes, and obesity may benefit from a less invasive endoluminal approach versus surgical bypass. These latest enhancements, including a lower profile, provide physicians with additional options for treating these patients.”
This innovative Viabahn device design reduces the delivery profile for larger 9–13mm diameter stent grafts by up to 3Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations, a Gore press release states. Additionally, new radiopaque markers on the distal and proximal ends enhance visualisation under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement.
“In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” says Yevgeniy (Eugene) Rits (Wayne State University; Detroit Medical Center; Harper University Hospital, Detroit, USA). “Combined with the trackability and flexibility I have always trusted with Viabahn devices, this new lower profile offering will become very instrumental in my dialysis access practice.”
Currently, the Viabahn device is indicated for use in superficial femoral artery (SFA) lesions, iliac lesions, in-stent restenosis of SFA lesions, and in stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts for haemodialysis.
