#SFHS2608600ADecree of 26 March 2026 on the Renewal of Registration and Modification of Registration Conditions for the NEURX DPS RA/4 Intra-Diaphragmatic Phrenic Nerve Stimulator by SYNAPSE BIOMEDICAL Europe
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This French decree renews and updates the reimbursement conditions for the NEURX DPS RA/4 phrenic nerve stimulator manufactured by Synapse Biomedical Europe. The device is listed under both Title I (accessories) and Title III (main products) of the Liste des Produits et Prestations Remboursables (LPPR). It is indicated exclusively for patients with high traumatic spinal cord injuries (strictly above C4) who are partially or fully dependent on mechanical ventilation. The updated text specifies strict patient eligibility criteria including minimum age of 1 year, intact C4 motor neuron, absence of intrinsic lung disease, no severe psychiatric disorders, and adequate nutritional status. Implantation requires a multidisciplinary team assessment and specific pre-implantation electrophysiological testing. The decree extends reimbursement until 1 February 2030 for the complete system (code 3442951, ref 20-0030), the external stimulator (code 3475608, ref 23-0021), and associated accessories (codes 1447499, 1413922, 1423850). The device is not MRI compatible.
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Key Changes
- Renewal of reimbursement registration for NEURX DPS RA/4 complete system until 1 February 2030
- Extension of reimbursement end date to 1 February 2030 for external stimulator (ref 23-0021) and accessories (codes 1447499, 1413922, 1423850)
- Updated patient eligibility: minimum age 1 year, partial or full ventilator dependence, intact C4 motor neuron confirmed by EMG
+ 3 more changes with Pro
Obligations
What this law requires
Limit NEURX DPS RA/4 reimbursement to patients with high traumatic spinal cord injuries strictly above C4 level who are partially or fully dependent on mechanical ventilation
Conduct multidisciplinary team assessment before implantation including pneumologist/physiologist, psychologist, social worker, surgeon, anesthesiologist-resuscitator, general practitioner, and physiatrist as indicated
Perform pre-implantation electrophysiological testing including surface diaphragmatic electromyography and mechanical measurement (trans-diaphragmatic pressure or esophageal/tracheal pressure with abdominal circumference) to verify C4 motor neuron integrity
Ensure only surgeons with visceral surgery competencies, laparoscopic expertise, and documented training in intra-diaphragmatic electrode implantation perform the procedure
Perform intra-operative mapping using the manufacturer's specific implantation kit to identify optimal stimulation sites before electrode placement