EUnetHTA Prioritisation List (EPL) – Other Technologies

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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. You may learn more about the details of the process in the pilot project plan here.

 

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. You may read more about the EUnetHTA Other Technologies assessment process and how manufacturers can be involved, here.

 

For more information, please contact LBI-HTA at eunethta@hta.lbg.ac.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, 2014 Yes, 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; imaging Cancer 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

LINK-
Prosigna
NanoString TechnologiesYesYes
MammaPrintAgendiaYesYes
IHC4 or IHC4+CNo informationLINK
Oncotype DX (with and without the recurrence score-pathology-clinical [RSPC] calculator)Genomic HealthYesYesLINK
Electroconvulsive therapy (ECT)Thymatron®Somatics Depression, 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 informationYes Yes, 2000 LINK
Transoral robotic surgery (TORS)da Vinci Surgical RobotIntuitive surgical Resection of oropharyngeal tumours or for obstructive sleep apneaEar, nose and throatClass IIbYes Yes --
Flex Robotic SystemMedRoboticsYesNo
Bulking agents Solesta®Salix Faecal incontinenceGastrointestinal, pancreatic and liver diseaseno informationYes Only for Solesta LINK-
PermacolTMCovidienLINK, LINK
BulkamidTMContura
PTQTMCogentix
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 1 Storz MedicalPseudarthrosisMusculosceletal No 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 CyclerFresenius No informationNo information
Sleep safe-SystemFresenius No informationNo information
Diabetic foot ulcers and leg ulcersUrgoStartUrgo MedicalInteractive dressing for treating diabetic foot ulcers and leg ulcersSkin disease, burn and wound careClass IIbYes No?LINK
Water steam ablation for benign prostatic syndromeRezumNxThera IncUsed for treating lower urinary tract symptoms presumed to be secondary to benign prostatic hyperplasia Men’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 sarcopeniaNo informationYes Yes LINKAssessment ongoing
Spinal cord stimulation system (Neuromodulation device that delivers electrical impulses to the spinal cord)Spectra WaveWriter
Boston Scientific Chronic 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, Montage
Boston Scientific
Freedom SCSStimwave
Senza®Nevro
AlgovitaNuvectra
PrimeAdvancedMedtronic
RestoreSensorMedtronic
Itrel 4Medtronic
IntellisMedtronic
St. Jude Medical Invisible Trial SystemSt. Jude Medical™
Stereotactic Body Radiation Therapy ( SBRT )VitalBeamVarian Medical SystemsLung, prostate, hepatic cancerCancer and palliative careClass IIIYesYes-Call ongoing
HalcyonVarian Medical SystemsYes, 2017Yes, 2017
Elekta UnityElekta ABYesYes
CyberKnife TDSAccuray YesYes