Pain and QoL Data Presented for Gore’s Viabahn Fortegra Venous Stent

April 22, 2026—Gore & Associates announced new 12-month findings from the global GORE VIABAHN FORTEGRA Venous Stent IVC trial, which evaluated treatment of patients with symptomatic deep venous iliocaval obstruction.

Robert A. Lookstein, MD, presented the data at SIR 2026, the Society of Interventional Radiology’s annual scientific meeting in Toronto, Canada, on behalf of the trial’s global Principal Investigators: Kush Desai, MD; Steven Abramowitz, MD; Erin Murphy, MD; and Stephen Black, MD.

According to the company, the new pain and quality-of-life (QoL) data showed the following in patients with deep venous disease after treatment with the Fortegra venous stent at 12 months:

• 81% of patients who experienced pain at baseline showed improvement, with median reduction in the pain score of –2.0 (P < .001).
• Clinically meaningful improvements were demonstrated across validated QoL measures (VEINES-QOL, EQ-5D-5L).
• Improvements were also observed in clinical severity measures, including edema and ulcer-related outcomes.

FDA approval of the Gore Viabahn Fortegra venous stent for the treatment of deep venous disease in the inferior vena cava, iliac, and iliofemoral veins was announced by Gore in January 2026.

In November 2025, the company announced that the trial met its primary endpoint, which evaluated device performance through 12 months in patients with symptomatic deep venous disease. The initial presentation of findings included primary patency of 83.4% overall with no device-related safety concerns observed. Dr. Black presented the data in November at the VEINS conference in Las Vegas, Nevada.