As of 8 October 2026, Intracept has a European CE mark (July 2025) and US FDA clearance. The first commercial European procedure was reported at Stoke Mandeville Hospital, England. NICE’s UK assessment is still in progress, which is not a recommendation for routine NHS use. For Australia and Canada, we found no national regulatory record. That does not mean it is unapproved. Boston Scientific · 2025 US FDA · 2022 NICE · 2026
Read these three questions separately
Regulation: may the device be marketed for this use? Availability: does a service currently offer it? Funding: will a public system or insurer pay? None of these automatically answers the others.
United Kingdom
Checked 8 October 2026. Boston Scientific announced the European CE mark on 24 July 2025 and named Stoke Mandeville Hospital as the site of the first commercial European procedure. That establishes a reported first case, not nationwide NHS access. Boston Scientific · 2025
NICE assessment GID-HTG10871 is in development, with its project status “In progress” and expected publication date “TBC”, as checked on 8 October 2026. An assessment in progress is not a recommendation for routine use. No national funding entitlement or verified UK price is established here. NICE · 2026
European Union
Checked 8 October 2026. The manufacturer’s July 2025 announcement reports CE marking and a limited European launch. CE marking does not establish availability in every country, reimbursement, or a provider near you. Check local service and payer information separately. Boston Scientific · 2025
United States
Checked 8 October 2026. FDA clearance is a device regulatory route. The official K222281 record is linked below; this is a documented later clearance record, not a claim about the system’s first clearance date. US FDA · 2022
CPT codes and some Medicare local coverage policies exist, but coverage varies by payer and jurisdiction. Ask for written confirmation of benefits, selection criteria and personal cost. A billing code does not guarantee reimbursement. CMS · 2026
Australia
Checked 8 October 2026. A Sydney provider page describes Intracept. It is a provider statement, not an independent confirmation of current access. A national registration record and routine funding pathway were not located in this review. This does not mean “not approved”. Spectrum Interventional Radiology · unda
Canada
Checked 8 October 2026. A verified national regulatory record, service pathway and funding policy were not located in this review. Ask a local clinician and payer to check current records. We do not infer lack of approval from lack of a source.
Questions before making plans
Ask the service whether it currently performs BVNA, which device it uses, who assesses suitability, which fees are included, what your payer has agreed in writing and how follow-up works. This guide is not a provider referral service and receives no referral fee.
A useful next stepLook at the treatment evidence →