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The TSA-II is a handheld vibrator and thermode device used for evaluating nerve impairment in small and large sensory fibers. It has unique features such as a wide stimulation range and a comprehensive report generator.
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TSA-II Applications & the Market
Thermodes: 30x30, 16x16 Calibration Kit VSA 3000 Hand held Vibrator CoVAS & TPS Software Hand-held Vibrator TSA-II • Neuro-Sensory Analyzer Thermal & Vibratory Quantitative Testing (QST) for evaluating nerve impairment in small and large sensory fibers
Small 16x16 mm Standard 30x30 mm TSA-II Unique features: • Wide stimulation range: 0°C to 50°C • Built-in Normative data with automatic conclusions • Comprehensive report generator • Thermodes of two sizes (mm): 30x30, 16x16
TSA-II Accessories: • VSA (Vibratory Sensory Analyzer) • Hand held vibrator • Computerized Visual Analog Scale (CoVAS) • Various thermode sizes (30x30 mm / 16x16 mm) • Digital Calibration Kit
TSA-II Main Applications: • Investigation of small & large fiber neuropathies • Early identification of neurological degeneration • Assists in treatment selection and follow-up • Rapid and reliable measurement of thermal-sensation and pain thresholds • Early detection of diabetic neuropathy of small nerve fibers • Efficient tool for detecting CRPS
TSA-II Clinical Applications
Small Fiber Neuropathy • Small Fiber Neuropathy (SFN) refers to a subtype of peripheral neuropathies characterized by the impairment of small A-delta and C-fibers • Standard electrophysiological tests such as Nerve Conduction Studies (NCS) and EMG reflect only large fiber function, leaving small fiber function unrepresented and the syndrome easily overlooked
Diabetic Neuropathy • Thermal sensation shows a higher incidence of abnormality than was revealed by either clinical examination or nerve conduction studies • Abnormal cold sensation is the most common finding in long-standing diabetic patients who has no other symptoms of neuropathy • These findings prove the importance of thermal QST for the early detection of diabetic neuropathy
Drug and Toxin induced neuropathy • Several chemotherapeutic drugs (such as vincristine, taxol and platinol), cause painful neuropathies • Detection of these painful neuropathies is supported by QST, often to the point of discontinuation of the use of a specific drug due to this neuropathy
CentralPost-Stroke Pain (CPSP) • Thermal QST has been found to be more sensitive than clinical examination in detecting sensory impairment in patients with sensory and sensory-motor stroke • QST performed on stroke patients can indicate the difference between neuropathic and non-neuropathic pain if evidence of a brain infract is not sufficient • Sensory deficit together with severe pain would support the diagnosis of central post-stroke pain (CPSP), while the absence of sensory loss might be relevant for musculoskeletal pain subsequent to the motor changes
Complex Regional Pain Syndromes(CRPS) • Hypoesthesia, allodynia, and hyperalgesia are frequent symptoms in CRPS type I patients • Evaluation of the thermal sensory pattern in CRPS I patients can improve the understanding of peripheral nerve function in these patients, and can be used in the assessment of therapy • QST can providing support for the diagnosis of CRPS II over CRPS I, as the differentiation depends on the presence of a lesion to a major nerve trunk, and thus affect the choice of therapy
Radiculopathy • Radiculopathy is usually caused by herniated disc pressure on the nerve root near the spinal cord. It is common for pain to occur with radiculopathy indicating that small fibers also became irritated • QST can be used to explore the different populations of fibers and dermatomes involved in lumbar Radiculopathy and to evaluate the severity of sensory dysfunction • Thermal QST can predict the degree of small fiber recovery following surgical decompression in the nerve root: High thresholds of warm sensation before surgery correlate with poor results after surgery, in patients with lumbar radiculopathy
Spinal Cord Injury • Low back pain radiating to the leg may be caused by various conditions such as radiculopathy, articular damage or muscular trigger points • Thresholds for cold sensation and cold pain have been found to be significantly higher in symptomatic patients. Patients who had abnormal neurological examination, had higher thresholds in the symptomatic compared with the non-symptomatic side • Thermal testing therefore is useful in the diagnosis of patients with radiating low back pain, in particular to identify those with neural damage
Whiplash Injury • Thermal testing is an important tool in the evaluation of acute whiplash among whiplash injured patients: Hypersensitivity to thermal stimuli allows the differentiation between higher levels of pain and disability and those with lesser symptoms • QST results in these patients may serve as an objective diagnostic tool for the assessment of possible damage to small sensory nerve fibers • Raised thermal thresholds in patients with chronic symptoms after whiplash injury may also suggest damage to the central trigeminal pathway in the upper spinal cord segments and the ponto-medullary levels of the brainstem
TSA-II The markets
The Pain Market Historically, pain clinics were an integral part of either the Anesthesiology or the Neurology departments. Today, pain is considered an independent discipline, and as such the number of pain clinics is rapidly growing. Almost every big hospital has its own pain clinic. Misdiagnosis and under-treatment of pain conditions are proven to be harmful, reinforcing the need for better pain management.
Growing Epidemic of Pain Chronic pain is considered the most costly health problem in North America, with annual cost of chronic pain in the U.S, is estimated to be $100B per year and over $300B costs due to loss of productivity Chronic pain is the number one cause of long-term disability in the United States, with over 100M patients in the US, and 1.5B patients worldwide According to a European Journal of pain, chronic pain affects over 19% of the European population, with undetermined cause for the pain in 80% of cases, and 85% of pain patients lack a specific diagnosis The worldwide neuropathic pain market is expected to increase from $5.5 billion in 2017 to $ 8.3 billion by 2024
TheDiabetic Neuropathy Market In the USA alone 23.6 million people (8% of the population!) have diabetes Only 17.9 million people are diagnosed, while 5.7 million people are not In 2007, a total of 1.6 million new cases of diabetes were diagnosed in people in the age of 20 or older The number of patients suffering from diabetes is growing every year. While in the past diabetes was considered a western illness, today it had spread to the Far East & Asia too
The Diabetic Neuropathy Market Severe forms of diabetic nerve disease are a major contributing cause of lower-extremity amputations 60% - 70% of people with diabetes have mild to severe forms of nervous system damage (painful and non-painful neuropathies) Continuous research is made in the field of Diabetic Neuropathy in order to find new methods for early diagnostics and treatment
The Diabetic Neuropathy Market Pharmaceutical companies (Eli Lilly, Takeda, Dainippon, etc.) invest billions of dollars, seeking for a compound / drug to cure diabetic neuropathy Medoc products, which are considered the Gold-Standard in QST, are used as a Primary or Secondary Efficacy Parameters in clinical trials Key opinion leaders in the field of diabetic neuropathy are using Medoc’s systems (Vinik, Bril, Tesfaye, Valensi, Ziegler, Kempler, Arezzo, Malik, Etc.)
The Pharmaceutical Trial Market • Medoc products are used by world-known pharmaceutical companies conducting clinical trials – such as Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Dainippon, Unilever, Quintiles, Pro-Derm, Sigma Tau, and others • Effectiveness and safety of prospective compounds for neurological, diabetic, and pain conditions can be established by examining small-fiber functionality using Medoc’s systems
The Pharmaceutical Trial Market Medoc’s systems can be used for a variety of applications in clinical trials • Phenotyping patients based on underlying pain mechanisms – Allowing to identify and recruit only patients who are expected to benefit from the treatment • Secondary outcome measures – quantitative and standardized secondary analgesic efficacy measures, to assess the analgesic efficacy and support extended labeling of the investigated compound • Safety outcome measures – monitor small fiber function and assure no ill effects are caused by the investigated compound