SI-Bone has announced that iFuse will be added to the List of Refundable Products and Services in France (Liste des Produits et Prestations Remboursables– LPPR), meaning that the French National Healthcare System will exclusively cover the iFuse procedure. Through the iFuse Implant System, the product has already been used in the minimally invasive surgical treatment of the sacroiliac (SI) joint.
Reimbursement, which is exclusive to the iFuse implant, has been established following the favourable opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS), begins 6 September, 2018 and is effective for an initial period of five years.
The CNEDIMTS concluded on 5 December, 2017, that the iFuse procedure’s observed outcomes, including improvements in quality of life and work status, are sufficient to include iFuse on the list of products and services provided for in Article L.165-1 of the Social Security Code. The Commission recommends brand name registration for the iFuse Implant System with the following indications: second-line treatment of sacroiliac joint dysfunction caused by sacroiliac joint disruption, or degenerative sacroiliitis in patients who fail to respond to conservative treatment.
Before treatment with iFuse, a diagnosis of unilateral or bilateral SI joint dysfunction must have been confirmed with positive responses to at least three out of the five SI joint provocative manoeuvres (iliac wing spacing test (distraction), iliac wings approximation test (compression), the vertical compression test of each SI joint (thigh thrust), the sacral test (Faber) and the shear test of the two supine SI joints (Gaenslen)), and a positive response to palpation of the SI joint. Patients who meet the above criteria may experience relief from diagnostic injections with anaesthetics and/or corticosteroid injections in the sacroiliac joint. If the clinical response to an anaesthetic injection is significantly positive, the sacroiliac joint may be considered as the source of the pain, and treatment with iFuse is indicated in the absence of any contraindications.
The commission recommends reserving the use of the iFuse Implant device to surgeons who are accustomed to using image-guided surgery and who have received specific training on the iFuse procedure.