Renal denervation

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in December 2023. Nine recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, and ophthalmological devices, as well as medical aids.

In July 2023, Health Technology Wales completed one full appraisal on wearable cardioverter defibrillators with the publication of Evidence Appraisal Report (EAR) and Guidance. Furthermore, in July 2023, Health Technology Wales decided to proceed with a full appraisal of radiofrequency renal denervation in the treatment of resistant hypertension based on the published Topic Exploration Report.

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.

On January 3, 2023, the Federal Joint Committee (G-BA) initiated the evaluation procedure concerning the method of renal denervation using ultrasound ablation in treatment-resistant hypertension (Paradise-System™ by ReCor Medical) within the framework of the early benefit assessment (in line with § 137h SGB V).

On December 17, 2022, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the transitional coverage for the renal denervation catheter SYMPLICITY SPYRAL.

In Q1 of 2022, Health Technology Wales (HTW) published one MedTech-related guidance on transcranial magnetic stimulation in depression treatment. A total of eleven Topic Exploration Reports (TERs) were released in Q1. Based on the TERs conclusions, HTW's Assessment Group decided to proceed with developing an Evidence Appraisal Report (EAR) and Guidance on one topic only - radiofrequency renal denervation for the treatment of resistant hypertension.

In October 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (genicular artery embolization for pain from knee osteoarthritis, laparoscopic renal denervation for loin pain hematuria syndrome, percutaneous endovascular forearm arteriovenous fistula creation for hemodialysis access), and one new Medical Technologies Guidance (DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography). Also, two new clinical guidelines were published.

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.