W L Gore & Associates Medical Products (Gore) has secured CE Mark approval under the EU's Medical Device Regulation (MDR) for its Gore Viabahn Fortegra venous stent to treat symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction.
The announcement follows a recent regulatory clearance in the US for the same device.
The venous stent is designed for patients with deep venous disease and features an open-structure, self-expanding wire-wound nitinol frame with a polymer lattice.
This device is intended to conform to individual patient anatomy while providing strength and resistance to compression and fracture. It is available in various sizes for different venous anatomies.
Clinical evaluation of the Fortegra venous stent was conducted in a prospective trial reported as the first to include IVC, iliac, and iliofemoral veins. Results indicated the device was safe and effective within its approved use.
Among patients who reported pain at baseline, 81% experienced improvement at the 12-month follow-up, with a median reduction in pain score of -2.0.
Additional findings showed improvements in quality-of-life indices and clinical severity outcomes, including measures of swelling and ulceration.
At 12 months, primary patency was reported at 83.4%, and no device-related safety concerns were identified.
Gore global primary investigator and Guy's and St Thomas' Hospital London venous surgery professor Stephen Black said: “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.”
Gore supplies devices for a range of cardiovascular and other medical conditions.
