The VELscope® Vx is an oral disease discovery device, not an oral cancer diagnostic device. The VELscope® is the first adjunctive device cleared by the FDA and Health Canada to help clinicians detect cancerous and precancerous lesions and other lesions that might not be apparent to the naked eye. The VELscope is also cleared to help surgeons determine appropriate surgical margins around lesions prior to excision.
The VELscope® Vx is LED Dental Inc.'s newest model release of the VELscope system, and has identical Indications for Use to the original VELscope system. The VELscope Vx is:
Simple to use
Involves no unpleasant rinses or stains
Adds only two minutes to the overall exam
The VELscope® Vx's blue light excites natural "fluorophores" in mucosal tissues. The VELscope® Vx's proprietary filter makes fluorescence visualization possible, by blocking reflected blue light, and by enhancing the contrast between normal and abnormal tissue.
Tissue fluorescence is an optical phenomenon that occurs when light absorbed by human tissue creates a molecular excitation that re-emits light at a different wavelength. It is important because it allows the clinician to see certain things in the tissue that are not visible any other way.
Like other visualization technologies, such as panoramic radiography, CT, MRI, PET and ultrasound, the VELscope is NOT a stand-alone diagnostic test. However, used in conjunction with the standard oral soft tissue exam, VELscope® Vx provides visual information that cannot be acquired in any other way.
In about 2 minutes, with no rinses, dyes or discomfort, a VELscope® Vx examination helps healthcare professionals assure their patients that their oral mucosa has been assessed to an advanced level of preventative care.
Yes, the VELscope® Vx system is safe. All that's being shone into the oral cavity is blue light, generated by light emitting diodes. However, patients with a history of photosensitivity or those using photosensitive medications should not be exposed to the light emitted from the VELscope® Vx device
In normal mucosa, the clinician will see recognizable fluorescence patterns determined by underlying physiological structure. In abnormal mucosa you will see disruptions to the normal mucosal patterning that will enable the clinician to better discern areas that require further attention. The ability to distinguish between normal and abnormal fluorescence patterns grows with the user's experience.
The most common locations for tobacco/alcohol associated OSCC are the lateral border of the tongue, floor of the mouth, lips, soft palate (including the tonsillar pillars) and the retromolar trigone. Lesions located on the lateral border of the tongue are often located just anterior to the foliate papilla. For the increasingly prevalent HPV-16 associated OSCC, the most common locations are associated with lymphoid tissue in the oropharynx and base of the tongue.
If you discover a lesion that appears to be severe, the patient should be immediately referred to a specialist. If you find an area that appears suspicious and you suspect a probable cause, address the root cause (e.g., anti-fungal medication for a fungal infection) and schedule the patient for a follow-up exam in 2-3 weeks to see if the area has resolved. If it hasn't and you are still uncertain about the cause, the lesion should be documented carefully, ideally including a fluorescence and white light photo taken with a digital camera attached to the VELscope® Vx. The patient should then be referred to a specialist for expert evaluation. Remember: the VELscope® Vx is intended to supplement, not replace, your clinical judgement.
The VELscope® Vx is a survey tool, not a diagnostic device specific to oral cancer. A misperception sometimes results when a lesion detected by the VELscope® Vx is biopsy-confirmed to be a non-cancerous form of oral disease. The job of the VELscope® Vx is to help clinicians detect any oral mucosal abnormality that could be cause for concern. A definitive diagnosis of cancer may be given only through surgical biopsy. Since the VELscope® Vx is an oral disease discovery device, not an oral cancer diagnostic device, it, by definition, cannot give a false positive (or false negative) diagnosis. However, some clinicians are under the misperception that a lesion discovered using an adjunctive device like the VELscope® Vx that is determined by biopsy to be noncancerous represents a false positive. In truth, discovering a lesion that is subsequently diagnosed as a noncancerous condition such as lichen planus, frictional keratosis or a viral or fungal infection is providing a valuable and health-enhancing service to the patient.
From an oral cancer perspective, an increasing percentage of oral cancers are discovered in patients with no known risk factors (such as tobacco usage or alcohol abuse); therefore many experts recommend all patients over the age of eighteen should be screened on at least an annual basis. This is truer than ever now that researchers believe that a particular strain of the human papilloma virus (HPV-16) is an increasingly frequent cause of oral cancer. Patients with significant risk factors should be screened at each recall appointment.
From a general perspective, the VELscope system is a great overall oral health assessment tool and is useful in highlighting many other kinds of oral problems that might otherwise go unnoticed. The VELscope can deliver great value to patients and has the potential to increase quality of life at every hygiene appointment – all at a very affordable cost.
The ViziLite system relies on light reflected from white lesions, and on the use of acetic acid to increase reflectance from areas ("acetowhitening" effect). This may enhance the visualization of some white lesions but doesn't differentiate between any of them. It does not visually enhance red lesions well, which is problematic, since red lesions are often aggressive. Acetic acid can also interfere with other procedures during the hygiene appointment, such as antimicrobial rinses, fluoride treatments and prophy pastes. Moreover, the acetic rinse is often the source of patient complaints. The per-patient cost may also be a concern with the ViziLite Plus.
At an average cost of $21.95 to the doctor, questions arise when patients don't want to pay the extra cost associated with the ViziLite Plus exam. The doctor has to either forgo the screening or pay for the procedure out of the practice's pocket. With VELscope® Vx, the per-patient cost for an exam is $1.96 for the disposable component. Assuming a VELscope® Vx exam fee of $15.00, at 4 screenings per day, ROI on the VELscope® Vx occurs in approximately 3 months.
Not surprisingly, surveys of practices that have switched from ViziLite Plus to VELscope indicate that virtually all are very pleased with their decision.
VELscope® Vx uses a completely different technology that is easier to use, less invasive, less costly for patients, offers superior detection capabilities and is more profitable for the practice. VELscope® Vx utilizes tissue fluorescence rather than the reflectance method used by the ViziLite. Tissue fluorescence allows clinicians to visualize lesions that are difficult or impossible to see under conventional lighting conditions. Tissue fluorescence reveals a great deal about structural and/or metabolic activity changes that are often directly related to disease processes. Chemical rinses, acetic acid rinses or stains are not required with VELscope® Vx, and the per-patient cost is less.
Please contact your preferred distributor regarding initial capital cost of the VELscope® Vx. However, once the unit has been fully amortized—which should take only a few months assuming an examination fee of $15 or so - the per-patient cost for the disposable component is approximately $1.96. This low per-patient cost allows the office to provide the service even when the patient does not agree to the additional cost of the exam.
With the first two generations of VELscope, practices often charged an exam fee of ~$35. With the lower-priced VELscope® Vx, offices can charge $15-$20 for the exam and still generate enough revenue to cover the purchase price of the device within only a few months.
CDT Code D0431 reads: "Adjunctive pre-diagnostic test that aids in the detection of mucosal abnormalities including pre-malignant and malignant lesions not to include cytology or biopsy procedures." More and more dental insurance plans are covering this procedure code. Patients will need to check with their individual plans for policy coverage.
Individual insurance companies may not cover this procedure and you will also be treating patients without insurance. It is important to educate your patients on the value of a thorough oral health examination and the benefits of the VELscope® Vx's fluorescence visualization during this necessary procedure. If the patient is still unwilling to pay, the low per-patient cost allows the office to provide the service at no cost if deemed necessary. Alternatively, some practices have chosen to not give their patients a choice, presenting the VELscope® Vx exam as part of the office's standard of care. Either way, patients are invariably impressed that their dentists are putting their oral health first, which builds trust in and respect for the dentist and staff. This contributes to a healthy, growing practice.
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