EUnetHTA Prioritisation List (EPL) – Other Technologies
EUnetHTA Prioritisation List for Medical Devices and In-Vitro Diagnostics
EUnetHTA publishes the EUnetHTA Prioritisation List (EPL) for Other Technologies (focus of the pilot was on medical devices and in vitro diagnostics).
This is the first time EUnetHTA has systematically sought to compile a list of medical devices and in vitro diagnostics that are of high interest and relevance for partner agencies and their national/regional contexts. By ensuring relevance to partner agencies, EUnetHTA seeks to achieve high uptake of the assessments at the national level in the partner countries.
These topics have been given priority based on the pilot on Topic Identification, Selection and Prioritisation (TISP). In this pilot, topics were identified by several sources and prioritised according to interest and relevance among partners.
Please note that EUnetHTA cannot guarantee that the topics will be assessed by EUnetHTA, but will strive to do so since these topics have shown to have high priority among partner HTA agencies. The topic will be assessed if sufficient number of EUnetHTA partners (at least four) are able to participate.
Medical device developers are encouraged to be involved in the assessment process as soon as it is confirmed that their product will be assessed. If this is the case, relevant manufacturers will be contacted by EUnetHTA.
For more information, please contact AIHTA at eunethta@aihta.at
Technology | Name of product | Manufacturer | Indication | Therapeutic area | Type of device according to CE marking | CE mark | FDA approval | Hyperlink to more information | EUnetHTA Status |
---|---|---|---|---|---|---|---|---|---|
Remote sensing of pulmonic pressure (Continuous monitoring of pulmonary artery pressure via an implanted leadless and battery less pressure sensor) | CardioMEMS HF System | St. Jude Medical | Patients with moderate to severe heart failure (to be verified with IFU) | Cardiovascular disease and vascular surgery | No information | Yes, 2011 | Yes, 2014 | – | |
Coronary lithoplasty | Coronary Lithoplasty System | Shockwave Medical | Treatment of coronary artery disease (to be verified with IFU) | Cardiovascular disease and vascular surgery | No information | Yes, 2017 | Yes, 2018 | – | |
Antibacterial envelope for cardiac implantable electronic devices | TYRX absorbable antibacterial envelope | Medtronic | To hold a pacemaker or implantable cardioverter defibrillator securely in place in order to provide a stable environment when implanted in the body (infection risk reduction) | Cardiovascular disease and vascular surgery | no information | Yes, 2014 | Yes, 2013 | LINK | |
Implantation of antibody-coated stents in coronary heart disease | COMBO™ Dual Therapy Stent | OrbusNeich | Acute coronary syndrome requiring percutaneous revascularization; any age or gender | Cardiovascular disease and vascular surgery | Class III | Yes, 2013 | No information | Saito et al., Eur Heart J 2018;39,2460–2468 | |
Colon capsule endoscopy (CCE-2) for the detection of colorectal polyps and cancer in adults with signs or symptoms of colorectal cancer or at increased risk of colorectal cancer / Camera pill versus colonoscopy for the diagnosis of colon cancer. | PillCam™ Colon 2 | Medtronic plc | Colorectal cancer; imaging | Cancer and Palliative care | No information | No information | Yes, 2014, classified as class II (US) | LINK | |
Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer | EndoPredict (EP score and EPclin score) | Myriad Genetics | Breast cancer | Cancer and Palliative Care | IVD | Yes, 2012 | No information | LINK | – |
Prosigna | NanoString Technologies | Yes | Yes | ||||||
MammaPrint | Agendia | Yes | Yes | ||||||
IHC4 or IHC4+C | No information | LINK | |||||||
Oncotype DX (with and without the recurrence score-pathology-clinical [RSPC] calculator) | Genomic Health | Yes | Yes | LINK | |||||
Electroconvulsive therapy (ECT) | Thymatron® | Somatics | Depression, schizophrenia, catatonia, status epilepticus, neuroleptic syndrome | Neurology and neurosurgery | No information | Yes | Yes | LINK | – |
spECTrum ECT Devices | MECTA | Yes | Yes | ||||||
Ectonustim Series 6 + | Ectron Ltd | Yes | No | ||||||
Radiofrequency uvulopalatoplasty | Surgitron Dual RF | Ellman International | Obstructive sleep apnoea | Ear, nose and throat | No information | Yes | Yes, 2000 | LINK | |
Transoral robotic surgery (TORS) | da Vinci Surgical Robot | Intuitive surgical | Resection of oropharyngeal tumours or for obstructive sleep apnea | Ear, nose and throat | Class IIb | Yes | Yes | – | – |
Flex Robotic System | MedRobotics | Yes | No | ||||||
Bulking agents | Solesta® | Salix | Faecal incontinence | Gastrointestinal, pancreatic and liver disease | no information | Yes | Only for Solesta | LINK | – |
PermacolTM | Covidien | LINK, LINK | |||||||
BulkamidTM | Contura | ||||||||
PTQTM | Cogentix | ||||||||
Durasphere® | June Medical | ||||||||
Gatekeeper® | Medtronic (THD, Italy aquired it) | ||||||||
THD Gatekeeper | Balmer | ||||||||
Chemohyperthermia | SYNERGO® | Synergo Medical | Non-muscle-invasive bladder cancer | Cancer and palliative care | No information | Yes | No information | – | |
Extracorporeal shockwave therapy (ESWT) | Duolith SD 1 | Storz Medical | Pseudarthrosis | Musculosceletal | No information | Yes | Yes, 2016 | – | |
Orthogold280 | MTS Medical UG/TRT | Yes | No information | – | |||||
Intermittent peritoneal dialysis | Homechoice Claria with Sharesource | Baxter | End stage renal failure | Renal disease and urology | Class II | Yes | Yes | – | – |
Homechoice Pro | Baxter | Yes | Yes | ||||||
Sleep safe harmony Cycler | Fresenius | No information | No information | ||||||
Sleep safe-System | Fresenius | No information | No information | ||||||
Diabetic foot ulcers and leg ulcers | UrgoStart | Urgo Medical | Interactive dressing for treating diabetic foot ulcers and leg ulcers | Skin disease, burn and wound care | Class IIb | Yes | No? | LINK | |
Water steam ablation for benign prostatic syndrome | Rezum | NxThera Inc | Used for treating lower urinary tract symptoms presumed to be secondary to benign prostatic hyperplasia | Men’s health and sexual health/ renal disease and urology | Class IIb | Yes, 2013 | Yes, 2015 | LINK Rezum LINK | |
Measurement of frailty in the elderly population | ARC-Solver Algorithm for Mobil-O-Graph | Austrian Institute of Technology (AIT), IEM GmbH | Geriatric frailty and sarcopenia | No information | Yes | Yes | LINK | Assessment ongoing | |
Spinal cord stimulation system (Neuromodulation device that delivers electrical impulses to the spinal cord) | Spectra WaveWriter | Boston Scientific | Chronic and drug-resistant pain | Musculosceletal/Orthopeadics | Class III | Yes (various devices in various years) | Yes (various devices in various years) | Guidance LINK Consultation Doc LINK | – |
Precision Plus, Spectra, Novi, Montage | Boston Scientific | ||||||||
Freedom SCS | Stimwave | ||||||||
Senza® | Nevro | ||||||||
Algovita | Nuvectra | ||||||||
PrimeAdvanced | Medtronic | ||||||||
RestoreSensor | Medtronic | ||||||||
Itrel 4 | Medtronic | ||||||||
Intellis | Medtronic | ||||||||
St. Jude Medical Invisible Trial System | St. Jude Medical™ | ||||||||
Stereotactic Body Radiation Therapy ( SBRT ) | VitalBeam | Varian Medical Systems | Lung, prostate, hepatic cancer | Cancer and palliative care | Class III | Yes | Yes | – | Call ongoing |
Halcyon | Varian Medical Systems | Yes, 2017 | Yes, 2017 | ||||||
Elekta Unity | Elekta AB | Yes | Yes | ||||||
CyberKnife TDS | Accuray | Yes | Yes |