Gore Wins FDA Nod for First On-Label Bridging Stent

Gore Medical has won FDA approval for an expanded indication of its VIABAHN VBX Balloon Expandable Endoprosthesis, making it the first bridging stent graft approved on-label for use in both fenestrated and branched endovascular aortic repair (FEVAR and BEVAR) in the United States. The company announced the approval on 14 October 2026, built on three-year outcomes from its EMBRACE registry presented days earlier at the European Society for Vascular Surgery meeting.

A bridging stent with no off-label workaround

FEVAR and BEVAR are minimally invasive techniques for complex aortic aneurysms that involve the renal or mesenteric arteries — cases a standard endograft cannot treat alone. The surgeon implants a custom-made endograft with fenestrations (openings) or side branches, then threads a separate bridging stent through each one to connect it to the target artery and keep blood flowing. For years, the bridging stent itself has been a balloon-expandable covered stent used off-label: cleared or approved for other indications, deployed in this role on the strength of published registries and individual surgeon judgment rather than a manufacturer-backed, FDA-reviewed indication.

What changed for vascular surgeons on October 14

01

First on-label bridge

VBX becomes the first device FDA has approved specifically as a bridging stent for both FEVAR and BEVAR, rather than one surgeons use for that purpose under an indication written for something else.

02

Customizable diameter and flare

The balloon-expandable design lets a surgeon size the stent's diameter and flare to a specific target vessel during the procedure, a fit other bridging options in use today also offer, but without FDA's review of that specific use.

03

Three years of registry evidence

The approval is backed by three-year outcomes from 268 patients across the EMBRACE registry's FEVAR and BEVAR cohorts, not a one-year snapshot.

What FDA actually expanded

The approval covers the use of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a bridging stent specifically in fenestrated and branched endovascular aortic repair — it does not change the device's existing iliac-artery indication, approved in 2017, and it is not a new product. Gore built its case on three-year results from the EMBRACE registry, a multicenter European study that began enrolling in 2023 to gather real-world data on VBX used this way, with target-vessel patency as its primary efficacy endpoint.

“The need for a standardized, evidence-based approach to bridging stent use has become increasingly important.” Gustavo Oderich, M.D., Professor and Chief, Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine — Gore’s 14 October 2026 announcement

VBX's FEVAR/BEVAR case, in four figures

1ston-label bridging stent approved for both FEVAR and BEVAR in the U.S.

97.5%3-year vessel-level primary patency, FEVAR (103 patients, 208 target vessels)

94.0%3-year vessel-level primary patency, BEVAR (165 patients, 454 target vessels)

2017year VBX first won FDA approval, for iliac artery lesions

Figures from Gore’s 14 October 2026 announcement and three-year EMBRACE registry results presented at the European Society for Vascular Surgery meeting, 6–9 October 2026.

Where VBX stands against the stents used off-label

VBX is not the only balloon-expandable covered stent surgeons reach for in FEVAR and BEVAR. Getinge’s Advanta V12, sold in the U.S. as the iCAST covered stent, won its own FDA premarket approval for bridging stent use in aneurysmal disease in July 2025 — but that U.S. label is written around a general aneurysmal-disease indication, not the FEVAR- and BEVAR-specific language Gore secured. Bentley InnoMed’s BeGraft Peripheral remains off-label for this use in both the U.S. and Europe, with a German physician-initiated study recruiting toward an on-label FEVAR indication. Gore’s approval is the first to carry FEVAR- and BEVAR-specific label language in the U.S.

VBX against the other bridging options

Product	Type	On-label for FEVAR/BEVAR	Manufacturer
GORE VIABAHN VBX	Balloon-expandable covered stent	Yes — FDA approved, Oct 2026	Gore Medical
Advanta V12 / iCAST	Balloon-expandable covered stent	General aneurysmal-disease bridging label (US, Jul 2025); not FEVAR/BEVAR-specific	Getinge
BeGraft Peripheral	Balloon-expandable covered stent	No — used off-label (on-label study ongoing in Europe)	Bentley InnoMed

From each company’s own labelling and published literature; not a clinical comparison.

What the aortic stent graft category is worth

$3.59B → $5.30B

Global aortic stent graft market, 2025 to 2030, as estimated by The Business Research Company (2026).

2025$3.59B

2026$3.87B

2030$5.30B

Sources: The Business Research Company, Aortic Stent Grafts Global Market Report 2026 · Technavio, Aortic Stent Grafts Market Analysis 2026-2030

Regulatory News outlook

We expect FEVAR/BEVAR bridging-stent volume to grow faster than the aortic stent graft category as a whole over the next few years, as an on-label option removes the documentation and liability friction that has slowed some centers’ adoption of fenestrated and branched repair for complex aneurysms; no publisher sizes that bridging-stent niche separately, so this is a directional view, not a figure of our own.

How we got here: Applying The Business Research Company’s published 7.9% compound annual growth rate to its $3.59 billion 2025 aortic stent graft baseline reaches roughly $5.30 billion by 2030; we have no independent figure for the FEVAR/BEVAR bridging-stent segment alone, so we read it as a faster-growing slice of that total rather than estimate a dollar figure for it.

From one iliac indication to two aortic ones

VBX's road to an on-label bridge

1. 2017

   First FDA approval

   VBX wins FDA approval for de novo or restenotic lesions in the iliac arteries — its original indication.

2. February 2023

   EMBRACE registry launched

   Gore begins a multicenter European registry evaluating VBX as a bridging stent in fenestrated and branched endografts, with target-vessel patency as the primary endpoint.

3. July 2025

   CE Mark for the bridging indication

   The same expanded FEVAR/BEVAR bridging indication wins a CE Mark under the EU MDR, following EMBRACE's earlier results.

4. 6–9 October 2026

   Three-year EMBRACE results presented

   Three-year outcomes across 268 FEVAR and BEVAR patients are presented at the European Society for Vascular Surgery meeting.

5. 14 October 2026

   FDA approval

   FDA approves the expanded FEVAR/BEVAR bridging indication in the U.S., making VBX the first on-label device for both procedures.

6. Ahead

   Longer-term registry follow-up

   Gore has not announced a date for results beyond three years, or for similar on-label reviews outside the U.S. and EU.

What the approval does not settle

An FEVAR/BEVAR-specific indication does not retire the Advanta V12/iCAST or BeGraft from these cases overnight: surgeons who have built case experience with another stent have limited reason to switch technique mid-practice, and Gore's announcement does not publish a specific PMA supplement number or detail how quickly hospitals are expected to update purchasing or protocols. What the approval changes is the paper trail — a documented, FDA-reviewed indication specific to FEVAR and BEVAR to point to, rather than a general aneurysmal-disease label or a published registry and individual judgment.

• What changed: VBX is now FDA-approved, not just used off-label, as a bridging stent in both FEVAR and BEVAR.
• Evidence base: three-year EMBRACE registry data across 268 patients (103 FEVAR, 165 BEVAR) and 662 target vessels.
• Not a new device: VBX's original iliac-artery indication dates to 2017; this is a label expansion.
• Not yet public: the specific PMA supplement number for this approval, which this article has not independently confirmed against FDA's own database.

Frequently asked questions

What did FDA approve for Gore's VBX stent graft?

An expanded indication allowing the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to be used as a bridging stent in fenestrated and branched endovascular aortic repair (FEVAR and BEVAR), announced 14 October 2026. It is the first device with that specific on-label indication for both procedures in the United States.

Is VBX a new device?

No. FDA first approved VBX in 2017 for iliac artery lesions. The 14 October 2026 decision expands its labeling; it does not introduce a new product.

What are FEVAR and BEVAR?

Fenestrated and branched endovascular aneurysm repair — minimally invasive techniques for treating complex aortic aneurysms that involve the renal or mesenteric arteries, using a custom-made endograft with openings or side branches that a separate bridging stent connects to those target vessels.

Why does on-label status matter if surgeons already used VBX this way?

Balloon-expandable covered stents, VBX included, have been used as FEVAR/BEVAR bridges off-label for years, without a manufacturer-backed indication or FDA-reviewed evidence specific to that use. An on-label indication gives surgeons and hospitals an FDA-reviewed data package and labeling to point to, rather than relying on individual judgment and published registries alone.