Gore today announced CE-mark approval for its Gore Viabhan Fortegra venous stent, which is indicated for use in the treatment of symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction. This latest milestone builds on the recent US Food and Drug Administration (FDA) approval.
A press release states that the Fortegra venous stent, the newest addition to the Viabahn device family, is specifically engineered to treat patients with deep venous disease. It consists of an open-structure, self-expanding wire-wound nitinol frame and a polymer lattice, which is designed for conformability, strength and fracture resistance.
According to Gore, this novel technology “helps provide an optimal balance and unique combination of allowing the stent to conform to the natural anatomy while providing compression resistance throughout the entire device”. Featuring a wide range of sizes, the Fortegra venous stent is noted to be appropriate for a wide range of patient anatomies.
“The Fortegra venous stent represents a significant advancement in the treatment of patients with the most difficult-to-treat venous obstructive pathology; occlusion of the inferior vena cava and iliac veins. Patients will benefit from a device that is specifically designed for this pathology and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through reconstruction of the iliocaval confluence and the unique properties of physiological movement in the inferior vena cava,” says Stephen Black (Guy’s and St Thomas’ Hospital, London, UK), co-principal investigator of the Fortegra venous stent IVC study.
The Fortegra venous stent was evaluated in a prospective trial—the first of its kind to include the IVC, iliac and iliofemoral veins. The results demonstrated the device to be both safe and effective for its indicated use in patients with deep venous disease.
Among patients that experienced pain at baseline, 81% showed improvement in pain at 12 months, with a median reduction in the pain score of -2.0 (p<0.001). Significant improvements were demonstrated across validated quality-of-life measures (VEINES-QOL, EQ-5D-5L), and improvements were observed in clinical severity measures, including oedema and ulcer-related outcomes. Primary patency remained high at 12 months (83.4% overall), with no device-related safety concerns observed.
“What is particularly important about this evidence is that it reflects the full thrombotic spectrum we treat in practice—acute, subacute, and post-thrombotic syndrome,” said Gerry O’Sullivan (Galway University Hospital, Galway, Ireland). “This prospective study demonstrated conclusively that patients benefitted from a device that is specifically designed for patients with complex cases involving the inferior vena cava, iliac veins and inflow veins. Results showed clinically meaningful benefits, alongside improvements in patient quality of life and clinical severity measures.”
