#SFHS2609156AOrder of April 1, 2026 on the renewal of registration and modification of registration conditions for SILK VISTA and SILK VISTA BABY self-expanding intracranial stents with controlled release (flow diverters) by BALT EXTRUSION
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This French regulatory order renews the reimbursement eligibility of SILK VISTA and SILK VISTA BABY flow-diverter stents manufactured by BALT Extrusion under Title III of the Liste des Produits et Prestations Remboursables. The stents are indicated exclusively for the treatment of unruptured intracranial aneurysms where the risk of spontaneous rupture exceeds the procedural risk and where the aneurysm cannot be treated by standard endovascular coiling (with or without assisting stents or balloons) or surgical methods. Decisions must be made via multidisciplinary consultation involving an interventional neuroradiologist, neurosurgeon, and neurologist. The order updates the company nomenclature, provides detailed product descriptions, and extends the reimbursement end date for eleven specific product codes until 15 June 2030. The measure takes effect on the thirteenth day after its publication in the Journal Officiel.
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Key Changes
- Renewal of reimbursement registration for SILK VISTA and SILK VISTA BABY flow diverter stents
- Updated company nomenclature entry for BALT Extrusion in the official list
- Reimbursement end date for codes 3138897, 3164096, 3190366, 3183395, 3114879, 3179560, 3152911, 3162039, 3144975, 3102273 and 3146431 extended to 15 June 2030
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Obligations
What this law requires
BALT Extrusion must ensure SILK VISTA and SILK VISTA BABY flow-diverter stents are only reimbursed for treatment of unruptured intracranial aneurysms where spontaneous rupture risk exceeds procedural risk and standard endovascular or surgical treatment is not feasible
All implantation procedures for SILK VISTA and SILK VISTA BABY stents must be performed by an interventional neurologist in a healthcare facility authorized for interventional neuroradiology procedures
Patient selection for SILK VISTA and SILK VISTA BABY stent implantation must be evaluated through multidisciplinary consultation including an interventional neuroradiologist, neurosurgeon, and neurologist
Aneurysm rupture risk assessment must be based on vascular risk factors (smoking, alcoholism, hypertension, female sex, age), family history, aneurysm size, shape, and location
Reimbursement eligibility for nomenclature codes 3138897, 3164096, 3190366, 3183395, 3114879, 3179560, 3152911, 3162039, 3144975, 3102273, and 3146431 is extended until 15 June 2030