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glucose sensor

Product Name: The PARADIGM VEO MMT-554
Country: France (FR)
Outcome Measure:

Primary - Efficacy of glycaemic control, extent this effect is maintained, Secondary - Compliance, satisfaction, quality of life (p. 11ff)

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gastric electrical stimulation device

Product Name: EnterraTM device
Country: United Kingdom (UK)
Outcome Measure:

Reducing symptoms, reducing requirement for nutritional support or hospitalisation, improving quality of life (p. 1)

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functional electrical stimulation device

Product Name: NESS L300 (Bioness Inc), Odstock Dropped Foot Stimulator (ODFS) (Odstock Medical Ltd), WalkAide (Innovative Neurotronics (p. 2)
Country: United Kingdom (UK)
Outcome Measure:

no a-priori outcomes defined

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foot pressure assessment device

Product Name: F-scan mat system
Country: Australia (AU)
Outcome Measure:

a. Efficacy: Observed risk of ulcer and amputation, diagnostic accuracy (Sensitivity, Specificity, positive and negative likelihood ratios, PPV, NPV, diagnostic odds ratios, ROC-curves, accuracy (p. 11)

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fixed appliances (brackets, bands)

Product Name:
Country: Belgium (BE)
Outcome Measure:

Treatment outcome, quality of life, self-esteem, attitude to health, malocclusion, health behaviour, patient participation, patient satisfaction, patient compliance, tooth ankylosis, tooth eruption, tooth ectopic, tooth impacted, tooth injuries, tooth loss, tooth resorption, tooth unerupted, diastema, multiple and congenital abnormalities, jaw malformation, cleft lip or cleft palate or cleft face, tooth disease (p. 21ff)

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continuous positive airway pressure (CPAP)

Product Name:
Country: United Kingdom (UK)
Outcome Measure:

a. Efficacy: Primary - Subjective sleepiness as assessed by the Epworth Sleepiness Scale, objective sleepiness as assessed by the Maintenance of Wakefulness Test, Osler test, Multiple Sleep Latency Test or equivalent measure Secondary - Blood pressure, cardiovascular disease (e.g. myocardial infarction, stroke), accidents (e.g. driving, occupational), quality of life, mood, anxiety and depression, simulated driving performance, neuropsychological functioning, apnoea–hypopnoea index /desaturation rate,<br>b. Safety: Any complications or adverse effects of treatment (p. 10)

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continuous positive airway pressure (CPAP)

Product Name:
Country: United Kingdom (UK)
Outcome Measure:

a. Efficacy: Snoring recording and/or acoustic analysis of snoring sound (snoring, sleep disturbance and daytime sleepiness, mean snoring volume, snoring index, percentage of sleep time spent in loud snoring, maximal sound intensity, snore energy ratio), polysomnography (PSG) (apnoea/hypopnoea index (events/hour), apnoea index (AI; events/hour), duration of obstructive respiratory pattern (minutes), oxygen saturation of arterial blood (SaO2) nadir, sleep efficiency (percentage of time asleep compared with time spent in bed) and total sleep time), modified PSG or oximetry outcomes, cephalometric radiographs or MRI scans of palatal length or width, Epworth Sleepiness Scale/symptoms of daytime sleepiness, patient and partner questionnaires and/or linear analogue scales related to snoring severity (it is recognised that patient reported snoring outcomes are of dubious validity as patients will only be able to report on what they have been told by their bed partners), patient and partner questionnaires and/or linear analogue scales related to quality of life, questionnaires and/or linear analogue scales related to sleep quality of bed partner, need for further repeat procedures<br>b. Safety: short- and long-term complications of treatment (e.g. nasal reflux on swallowing, temporal mandibular joint pain, pain, speech, swallowing difficulties and pharyngeal irritation (p. 11ff)

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balloon cryoablation catheter (balloon cryoablation for pulmonary vein isolation)

Product Name:
Country: United Kingdom (UK)
Outcome Measure:

a. Efficacy: Specialist Advisers key efficacy outcomes: Electrical isolation of 'all pulmonary veins' or 'all 4 pulmonary veins', procedure duration, freedom from atrial fibrillation, avoidance of repeat procedures and reduced use of anti -arrhythmic drugs<br>b. Safety: Specialist Advisers theoretical adverse events include death, atrio-oesophageal fistula permanent phrenic nerve palsy, damage to structures anatomically close to pulmonary veins, deep vein thrombosis (p. 3ff)

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balloon catheter (venoplasty)

Product Name:
Country: Canada (CA)
Outcome Measure:

Safety, efficacy, diagnostic performance (p. 2)

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automatic injection devices (i.e. insulin pump)

Product Name: ACCU-CHEK Spirit, Animas 2020, MiniMed Paradigm 522/722
Country: Canada (CA)
Outcome Measure:

a. Safety: Safety outcomes, including adverse events (diabetic ketoacidosis, severe hypoglycaemia)or complications (infections, pump malfunction);<br>b. efficacy and effectiveness outcomes include glycaemic control (e.g., glycosylated haemoglobin), patient satisfaction and quality of life, secondary complications of diabetes, neuro-cognitive function and behaviour changes in children if applicable, pregnancy outcomes if applicable (p. 48)

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autofluorescence visualisation device

Product Name: Velscope
Country: Australia (AU)
Outcome Measure:

no a-priori outcomes defined

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assistive listening devices (personal frequency modulation (FM) systems, infrared systems, induction loop system, one-to-one communicators, telephone amplifying devices for cordless, cell, digital and wired phones, amplified answering machines, amplified telephones with different frequency responses; paging systems, computers; and wake-up alarms)

Product Name:
Country: New Zealand (NZ)
Outcome Measure:

- Outcome measures for communication needs and function such as Client Oriented Scale of Improvement (COSI), Expected consequences of Hearing Aid Ownership (ECHO)<br>- Self-report measures such as Abbreviated Profile of Hearing Aid Benefit (APHAB), haring

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anti-infective central venous catheters treated with anti-infective agents

Product Name:
Country: United Kingdom (UK)
Outcome Measure:

a. Safety: Primary - catheter related bloodstream infection, Secondary–colonisation, clinical symptoms, local clinical signs, death<br>b. Efficacy: Primary - Catheter-related bloodstream infection avoided, case detected (p. 7)

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Scalable Medical Alert Response Technology (SMART)

Product Name: SMART system
Country: Australia (AU)
Outcome Measure:

no a-priori outcomes defined

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Pulmonary artery catheter (PAC) device, Heart Balloon Catheter, Central Venous Pressure (CVP) catheter

Product Name:
Country: Australia (AU)
Outcome Measure:

a. Efficacy: Primary - Morbidity, mortality, quality of life, Impact on patient management: treatment instigated, treatment avoided, investigations avoided, Secondary - Length of hospital stay, length of intensive care stay (p. 30)<br>b. Safety: pulmonary artery rupture (fatal/non-fatal), other complications (pneumothorax, bleeding, arrhythmia, infection, insertion complications, surgery) (p. 30)

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PARADIGM VEO monitor/insulin pump

Product Name: The PARADIGM VEO MMT-554
Country: France (FR)
Outcome Measure:

Primary - Efficacy of glycaemic control, extent this effect is maintained, Secondary - Compliance, satisfaction, quality of life (p. 11ff)

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MRI-safe Incubator

Product Name: LMT nomag IC 1.5, IC 3.0
Country: Australia (AU)
Outcome Measure:

no a-priori outcomes defined

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MRI guided focussed ultrasound system, hyperthermia system

Product Name: ExAblate® 2000 system
Country: Australia (AU)
Outcome Measure:

no a-priori outcomes defined

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extracorporeal shock-wave therapy (ESWT)

Product Name: Aries Dornier Epos™ Ultra Dornier Med Tech GmbH, Cardiospec™ Medispec GmbH, CELLACTOR® SC1 Storz Medical AG, CellSonic CellSonic Ltd., D-ACTOR® 100+200 Storz Medical AG, Dermagold 100, Orthogold (100, 180, 180C, 280) MTS Medical UG, dermaPACE Sanuwave Health, Inc., Duoclast® (smart, classic, master) Electro Medical Systems, Duolith® (SD1, SD1 T-TOP, SD1 ultra) Storz Medical AG, Gymna ShockMaster 300 GymnaUniphy N.V., Gymna ShockMaster 500 GymnaUniphy N.V., Health Tronics OssaTron Sanuwave Health, Inc., Lithogold 380 MTS Medical UG, Lithowave 360CS MTS Medical UG, Masterpuls® (MP50, MP100, MP200) Storz Medical AG, Modulith® SLC Storz Medical AG, Orbasone Pain Relief System Orthometrix, Inc., Orthima DirexGroup,orthoPACE Sanuwave Health, Inc., Orthospec™ ESWT Medispec GmbH, Piezo Wave Richard Wolf GmbH, Piezoclast Electro Medical Systems, PiezoSon 100™ plus Richard Wolf GmbH, Radialspec™ Medispec GmbH, SONOCUR basic + plus Siemens Medical Solutions,Inc.
Country: Austria (AT)
Outcome Measure:

a. Efficacy: Union rate, time to fracture union, function, pain, quality of life<br>b. Safety: Morbidity (p. 13)

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extracorporeal shock wave therapy device

Product Name:
Country: Australia (AU)
Outcome Measure:

a. Efficacy: Primary - mortality/survival, ulceration, amputation, recurrence rates, mobility restriction, quality of life, independence, long term mobility, healing,<br>Secondary - Percentage healing, general functioning, deformity and pre-ulcer lesions, hospitalisation, average length of stay<br>b. Saftey: harms, side effects (p. 497)

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Total: 457 Entries
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