EUnetHTA Prioritisation List (EPL) – Other Technologies

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

TechnologyName of product ManufacturerIndicationTherapeutic areaType of device according to CE markingCE markFDA approvalHyperlink to more informationEUnetHTA Status
Remote sensing of pulmonic pressure
(Continuous monitoring of pulmonary artery pressure via an implanted leadless and battery less pressure sensor)
CardioMEMS HF SystemSt. Jude MedicalPatients with moderate to severe heart failure (to be verified with IFU)Cardiovascular disease and vascular surgeryNo informationYes, 2011Yes, 2014 
Coronary lithoplastyCoronary Lithoplasty SystemShockwave MedicalTreatment of coronary artery disease (to be verified with IFU)Cardiovascular disease and vascular surgeryNo informationYes, 2017Yes, 2018 
Antibacterial envelope for cardiac implantable electronic devicesTYRX absorbable antibacterial envelopeMedtronicTo 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 surgeryno informationYes, 2014Yes, 2013LINK 
Implantation of antibody-coated stents in coronary heart diseaseCOMBO™ Dual Therapy StentOrbusNeichAcute coronary syndrome requiring percutaneous revascularization; any age or genderCardiovascular disease and vascular surgeryClass IIIYes, 2013No informationSaito 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 2Medtronic plcColorectal cancer; imagingCancer and Palliative careNo informationNo informationYes, 2014, classified as class II (US)LINK 
Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancerEndoPredict (EP score and EPclin score)Myriad Genetics

Breast cancerCancer and Palliative CareIVDYes, 2012

No information

ProsignaNanoString TechnologiesYesYes 
IHC4 or IHC4+C  No informationLINK
Oncotype DX (with and without the recurrence score-pathology-clinical [RSPC] calculator)Genomic HealthYesYesLINK
Electroconvulsive therapy (ECT)Thymatron®SomaticsDepression, schizophrenia, catatonia, status epilepticus, neuroleptic syndromeNeurology and neurosurgeryNo informationYesYesLINK
spECTrum ECT DevicesMECTAYesYes 
Ectonustim Series 6 +Ectron LtdYesNo 
Radiofrequency uvulopalatoplastySurgitron Dual RFEllman InternationalObstructive sleep apnoeaEar, nose and throatNo informationYesYes, 2000LINK 
Transoral robotic surgery (TORS)da Vinci Surgical RobotIntuitive surgicalResection of oropharyngeal tumours or for obstructive sleep apneaEar, nose and throatClass IIbYesYes
Flex Robotic SystemMedRoboticsYesNo
Bulking agentsSolesta®SalixFaecal incontinenceGastrointestinal, pancreatic and liver diseaseno informationYesOnly for SolestaLINK
PermacolTMCovidienLINK, LINK
Durasphere®June Medical
Gatekeeper®Medtronic (THD, Italy aquired it)
THD GatekeeperBalmer
ChemohyperthermiaSYNERGO®Synergo MedicalNon-muscle-invasive bladder cancerCancer and palliative careNo informationYesNo information 
Extracorporeal shockwave therapy (ESWT)Duolith SD 1Storz MedicalPseudarthrosisMusculosceletalNo informationYesYes, 2016 
Orthogold280MTS Medical UG/TRTYesNo information 
Intermittent peritoneal dialysisHomechoice Claria with SharesourceBaxterEnd stage renal failureRenal disease and urologyClass IIYesYes
Homechoice ProBaxterYesYes
Sleep safe harmony CyclerFreseniusNo informationNo information
Sleep safe-SystemFreseniusNo informationNo information
Diabetic foot ulcers and leg ulcersUrgoStartUrgo MedicalInteractive dressing for treating diabetic foot ulcers and leg ulcersSkin disease, burn and wound careClass IIbYesNo?LINK 
Water steam ablation for benign prostatic syndromeRezumNxThera IncUsed for treating lower urinary tract symptoms presumed to be secondary to benign prostatic hyperplasiaMen’s health and sexual health/ renal disease and urologyClass IIbYes, 2013Yes, 2015LINK

Rezum LINK
Measurement of frailty in the elderly populationARC-Solver Algorithm for Mobil-O-GraphAustrian Institute of Technology (AIT), IEM GmbHGeriatric frailty and sarcopenia No informationYesYesLINKAssessment ongoing
Spinal cord stimulation system (Neuromodulation device that delivers electrical impulses to the spinal cord)Spectra WaveWriterBoston ScientificChronic and drug-resistant painMusculosceletal/OrthopeadicsClass IIIYes (various devices in various years)Yes (various devices in various years)Guidance LINK
Consultation Doc LINK
Precision Plus, Spectra, Novi, MontageBoston Scientific
Freedom SCSStimwave
Itrel 4Medtronic
St. Jude Medical Invisible Trial SystemSt. Jude Medical™
Stereotactic Body Radiation Therapy ( SBRT )VitalBeamVarian Medical SystemsLung, prostate, hepatic cancerCancer and palliative careClass IIIYesYesCall ongoing
HalcyonVarian Medical SystemsYes, 2017Yes, 2017
Elekta UnityElekta ABYesYes
CyberKnife TDSAccurayYesYes
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