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FDA approvedFDA approved. Stage 4 of 4 (Authorized)

FDA Approves Gore's Viabahn Fortegra Stent for Inferior Vena Cava Obstruction

The venous stent, formerly called Viafort, was approved on data from an 89-patient trial, and the FDA has ordered two further studies to follow its performance.

By News DeskJanuary 8, 20262 min read
Anatomical drawing of the veins of the pelvis from Gray's Anatomy
An anatomical plate from Gray's Anatomy showing the veins of the pelvis, including the iliac veins. Not the Viabahn Fortegra stent described in this article. Henry Gray (Gray's Anatomy), public domain, via Wikimedia Commons · Public domain
FDA approvedPMA, high-risk device · P250017FDA approved. Stage 4 of 4 (Authorized)

The FDA approved this high-risk device through premarket approval (PMA), after reviewing clinical evidence of safety and effectiveness.

Key points

  • The FDA approved the Gore Viabahn Fortegra Venous Stent under premarket approval P250017 on December 19, 2025; Gore announced it on January 6, 2026.
  • It is indicated for symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction.
  • Gore reported 83.4% primary patency at 12 months in its 89-patient trial; the FDA requires continued follow-up to 60 months and a new 150-patient US study.

W. L. Gore & Associates said on January 6 that the US Food and Drug Administration has approved its Viabahn Fortegra Venous Stent, previously known as the Viafort Vascular Stent, for blockages of the inferior vena cava, the large vein that returns blood from the lower body to the heart, according to the company's announcement.

The FDA's premarket approval database lists the device as P250017, a vena cava stent. The agency received the application on June 20, 2025, and approved it on December 19, 2025. The approved indication is "the treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction."

Gore calls the stent the first device for the treatment of deep venous disease in the inferior vena cava, iliac and iliofemoral veins; that is the company's description. The device previously received breakthrough device designation from the FDA, the company said.

How the device is built

According to Gore, the stent combines an open-structure, self-expanding wire-wound nitinol frame with an expanded polytetrafluoroethylene polymer lattice, a design the company says is meant to let the stent conform to the anatomy while resisting compression along its full length. It joins Gore's Viabahn device family and comes in a wide range of sizes.

Trial results

The approval rests on an international trial that treated 89 patients with deep venous disease. As summarized in Gore's release and reported by Endovascular Today, all patients were treated for thrombotic disease, 94.3% had lesions spanning three vessel regions and 68.5% needed stents extending below the inguinal ligament into the common femoral vein.

Gore reported 12-month primary patency in 83.4% of patients, with 96.5%, 88.9% and 89.8% primary patency in the inferior vena cava, left iliofemoral and right iliofemoral regions. The company said there were no stent embolizations or migrations, fractures, vascular injuries or clinically significant pulmonary embolisms through 12 months, and no device-related deaths or major bleeding through 30 days. Overall, the study met its 12-month composite efficacy and safety primary endpoint, Gore said. These are company-reported results.

"Patients will benefit from a device that is designed specifically for this disease and its unique anatomic and physiologic challenges," said Kush Desai, the trial's national primary investigator, in the release.

Required follow-up

The FDA's approval order requires two post-approval studies. The first continues follow-up of the pivotal trial, which treated 55 patients at eight US sites and 34 at nine sites outside the US; at the time of the data export, 85 patients were still active and will be followed through 60 months.

The second is a new single-arm study that will enroll 150 patients at up to 35 US sites, with follow-up through 36 months. Its primary endpoints are primary patency through 12 months and freedom from device- or procedure-related serious adverse events through 30 days.

Sources

  1. Gore Gains FDA Approval for First Deep Venous Stent Indicated for the IVC and Iliofemoral Veins, W. L. Gore & Associates, January 6, 2026
  2. PMA P250017: Gore Viabahn Fortegra Venous Stent (database record), US Food and Drug Administration, December 19, 2025
  3. P250017 approval order, US Food and Drug Administration, December 19, 2025
  4. Gore's Viabahn Fortegra Venous Stent Wins FDA Approval, Endovascular Today, January 6, 2026