Cardiovascular devices

On November 9, 2020, in accordance with §137h Paragraph 6 SGB V, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency within the framework of the early benefit assessment.

In October 2020, a completed mini-method assessment for the coronary sinus reducer stent (Neovasc) implantation in refractory angina pectoris treatment was published within the New Methods framework. The Oslo University Hospital carried out the evaluation. The technology was recommended for routine use in hospitals.

The French National Authority for Health (HAS) released new decisions about intra-DRG reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern cardiac sutureless valve bioprostheses and implantable devices for the treatment of urinary incontinence.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 12735 of August 13, 2020, Tuscany Regional Healthcare has published assessments of eleven medical devices of various therapeutic areas, including peripheral nerve stimulator, catheter for renal denervation, EKOS technology and others.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern drug-eluting coronary stents, TAVI, orthopedic appliances, wound dressing, stoma obturator, toric intraocular lens.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is currently performing a theme survey for medical technology products for ischemic heart disease and heart failure. The submissions in relation to this survey will be closed on August 21, 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published five decision support documents. The assessed technologies included implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure, intrauterine ultrasound-guided transcervical radiofrequency ablation, percutaneous transvascular implantation of a coronary sinus reducing stent, radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer, and Vascular photodynamic therapy with Padeliporfin (Tookad® solution).

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 9004 of June 18, 2020, Tuscany Regional Healthcare has published assessments of nine medical devices of various therapeutic areas.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2020 concern various types of devices, including cardiovascular devices (self-expanding intracranial stents, TAVI), CT navigation kit for CT-guided percutaneous interventions and medical aids. A total of 8 decisions were made.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in April 2020 concern various types of devices, for example, cardiovascular and orthopaedic devices, diabetes management systems, and other types of devices. A total of 15 decisions were made.

With a regional decree 381 of March 23, 2020, Tuscany Regional Healthcare has published clinical guidelines on the appropriateness of use and indications on the variability of the consumption of the stents for the arteriopathy of the lower limbs, the carotid stents, and the coronary stents.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 3047 of March 2, 2020, Tuscany Regional Healthcare has published assessments of eight medical devices of various therapeutic areas.