‘W.L. Gore & Associates’

FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. Additionally, the company says VBX now offers the most 6 Fr-compatible configurations among balloon-expandable stent grafts.

Dr. Darren Schneider and his team at Penn Medicine completed the first commercial implant of the new system.

“Combined with the flexibility, strength and deployment accuracy I’ve always trusted with the device, the new lower profile will enable me to treat most of my complex cases with a 6 or 7 Fr device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of …

The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition.

Dr. Fakhir Elmasri and a team at Lakeland Vascular Institute (Lakeland, Florida) were among the first to enroll patients. Elmasri, an interventional radiologist, said the results should inform device selection for durable outcomes in the future. Dr. Prakash Krishnan at Mount Sinai (New York) said the study could answer the question around superior modalities.

Gore plans to enroll an estimated 244 subjects across 40 sites in the U.S., Australia, New Zealand and Europe. The trial randomizes patients 1:1 for the VBX stent graft group or the bare m…

The FORWARD study evaluates the methods in the treatment of complex iliac occlusive disease. Gore’s prospective, multicenter, randomized controlled trial includes up to 40 sites in the U.S., Australia, New Zealand and Europe. The company estimates a total of 244 subjects randomized 1:1 between VBX stent graft and the bare metal stent control. Patients follow-up spans up to five years from the initial procedure.

Gore defines the primary endpoint as primary patency through one year. Secondary endpoints address technical success, acute procedural success, clinical success and additional patency. They also look at target lesion revascularization outcomes and patient improvement metrics.

The company expects one-year results in 2027.

Dr. Melissa Kirkwood of the Universi…

The prospective, non-randomized, multi-center, single-arm study will have a five-year follow-up and will evaluate the investigational Gore ViaFort vascular stent for the treatment of symptomatic iliofemoral venous obstruction. It will evaluate the device in a treatment range of 10 to 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption.

The first patient was enrolled by David Dexter at Sentara Vascular Specialists in Norfolk, Virginia.

“With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the ViaFort device is compelling to use in a clinical trial,” Dexter …