Italy

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

In late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.”

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders.

On 7th of November, 2018, the Italian Ministry of Health announced that the technical standards for magnetic resonance and its use are updated.

On 3rd of October, 2018, the Italian Agency for Regional Healthcare Services, AGENAS, announced on their website that the reviewer volunteers are needed for reviewing the reports that should be published soon.

In the early July 2018, the authorities of the Italian region Veneto brought a decree that updates the regional guidelines for the management of patients with colostomy, ileostomy and urostomy that were published in January 2017.

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

On 26th April, the Italian national agency for regional healthcare, AGENAS, announced that five new HTA documents will be produced for medical technologies during the next months.

Emilia Romagna Region published a preliminary information report on the Equistasi® device, a wearable proprioceptive stabilizer for rehabilitation of postural instability in Parkinson's disease, multiple sclerosis and athletes.