FDA approves Gore low-profile balloon-expandable endoprosthesis

The Viabahn VBX. [Image courtesy of Gore]W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis.

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 …

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Gore enrolls first patients in expandable stent graft trial

The VBX stent graft. [Image courtesy of Gore]W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft.

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…

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Gore initiates study to compare VBX stent graft, metal stenting

The VBX stent graft. [Image courtesy of Gore]Gore announced today that it initiated a clinical study comparing its VBX stent graft to bare metal stenting.

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.

Gore seeks head-to-head data

Dr. Melissa Kirkwood of the Universi…

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Gore enrolls first patient in Gore ViaFort vascular stent iliofemoral study

The Viafort vascular stent. [Image courtesy of Gore]Gore this week announced it enrolled the first U.S. patient in its pivotal study for its ViaFort vascular stent.

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 …

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Junkosha names new US leadership

Joe Rowan is retiring as CEO and president of Junkosha USA. [Photo courtesy of Junkosha]

Japanese fluoropolymer supplier Junkosha today announced new leadership for its U.S. subsidiary.

Joe Rowan has retired as CEO and president of Junkosha USA but will remain as an advisor as Mike Winterling takes over as chief operating officer.

“Our aim is to be acknowledged as the most responsive partner for specialized high-performance polymer solutions; to be organizations’ No. 1 partner by meeting their unmet needs and ultimately being easy to do business with,” Junkosha CEO and President Mamoru Sogo said in a news release. “This is what we have always strived to do and will further expand our global presence into the future with Mike as he takes over from Joe as part of our succession plan.”

Rowan founded Irvine, California-based Junkosha USA, which sells fluoropolymer-based medical components …

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Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical

Left: the Endurant II. Right: the Excluder AAA. [Images from the websites of Medtronic and Gore]Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems.

The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family.

Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the trial. After that, the plan is to randomize patients to receive endovascular aneurysm repair (EVAR). The EVAR would come from either the Endurant or Excluder families of grafts. Follow-up comes at one month, one year and annually throughout five years.

Dr. Ray Workman and his team at Novant Health Forsyth Medical Center (Winston-Salem, North Carolina) enrolled the first patient.

“Through the Advance trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient…

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