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JORF · 27 Aug 2026 · 9 vistas

Expanded reimbursement for the GORE VIABAHN PROPATEN stent

Por FactBox Admin

The Ministry of Health, Families, Autonomy and People with Disabilities renews the registration of the GORE VIABAHN PROPATEN self-expanding covered endoprosthesis from the company WL GORE & Associates and expands the indications covered under Title III of the list of reimbursable products and services. The decision is published in JORF No. 0199 of August 27, 2026, under reference NOR SFHS2622729A, in an order signed on August 24, 2026.

The order modifies the registration conditions for this stent, whose internal surface is coated with porcine-derived heparin, registered under Title III of the list provided for in Article L. 165-1 of the Social Security Code. It falls within the framework of the regulation of implantable medical devices and European Regulation 2017/745.

Expanded Covered Indications

The “covered indications” paragraph is entirely replaced. The device remains covered for symptomatic peripheral artery disease (PAD) at the stage of severe intermittent claudication (stage ≥ 2b according to the Leriche and Fontaine classification) or critical ischemia, for de novo complex lesions of 15 to 25 cm of class C and D (TASC II classification) of the femoro-popliteal arteries above the knee.

The indication for popliteal artery aneurysm (PAA) is maintained and specified for patients ineligible for surgery:

  • symptomatic or asymptomatic aneurysm ≥ 20 mm in diameter;
  • or aneurysm < 20 mm with a mural thrombus.

Expanded Technical Characteristics

The range of diameters and lengths covered for the PAA indication is significantly expanded:

  • diameters from 5 to 13 mm (compared to 9 to 13 mm previously);
  • lengths from 2.5 cm to 25 cm (compared to 5 to 15 cm previously);
  • compatibility with 75 and 120 cm catheters and 0.014, 0.018, and 0.035 inch guidewires.

For the PAD indication, the order adds that the implantation decision must be made within the framework of a multidisciplinary consultation. The paragraph regarding the MRI compatibility of the device is deleted.

Duration of Coverage

The coverage end date is extended to July 1, 2029, for nomenclature codes 3280201, 3280371, 3257515, 3249042, 3226710, and 3288332. The order takes effect on the thirteenth day following its publication in the Official Journal of the French Republic.

For vascular patients, this expansion increases access to reimbursement for a stent intended for the treatment of PAD and popliteal aneurysm, notably by expanding the covered device sizes and framing the implantation decision through a multidisciplinary consultation.

Source: Decree of August 24, 2026, NOR SFHS2622729A, published in JORF No. 0199 of August 27, 2026 (Official Journal of the French Republic).