FAQ

clinical

How can I find the most recent peer-reviewed articles on Optical Coherence Tomography (OCT)?

A growing number of medical and scientific journal publications citing OCT are listed under the References page of the Imalux web site. You may contact Imalux for additional information. Alternatively, standard bibliographical medical and science citation search engines (i.e. Medline) can be used.

What are the indications of the Niris Imaging System?

The Niris Imaging System is indicated for use as an imaging tool in the evaluation of tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

What is “tissue microstructure”?

Tissue microstructure is the spatial distribution of (histo)morphological features and elements at a spatial scale between 10 micrometers (µm) and several millimeters (mm).

What is the breakthrough that OCT offers in clinical diagnostic and treatment procedures?

The Niris Imaging System provides a solution to a previously unmet need as physicians can now visualize in real time below the tissue surface at a spatial resolution better than that currently available in point-of-use imaging systems, such as ultrasound. The Niris Imaging System depth range of 1-2 mm is comparable to the depth of many biopsies, which is the gold standard in the diagnosis of many diseases, including cancer.

The Niris Imaging System’s image depth and spatial resolution enable the physician to visualize the tissue microstructure, which is beyond that which is visually observable with white light. Many clinical investigations with OCT have demonstrated that disruptions in the tissue microstructure may be indicative of the presence of an abnormal tissue states. Refer to the References on Imalux’s web site for peer-reviewed clinical publications.

Can OCT detect diseases, such as cancer?

Imaging equipment does not detect pathological conditions by itself. Rather, imaging equipment offers the physician additional clinical information during the diagnostic and treatment process. The Niris Imaging System provides high spatial resolution images that add to the physician’s clinical information in determining the presence of a disease, such as cancer, and in verifying the efficiency of the treatment.

What is “real-time” imaging? Is it instantaneous?

All imaging equipment requires some finite time to scan and acquire an image. The Niris Imaging System acquires an individual scan in approximately 1 second, which can be considered “real-time” in the sense that the System can acquire images directly at the point-of-use and does not require a separate radiology visit (i.e., MRI) and/or time to develop images (i.e., x-ray).

product

What is “Near InfraRed Light”?

Near InfraRed (NIR) light is light with a range of wavelengths from approximately 800 – 1300 nm (nanometers). This light wavelength is above the visible spectrum (400 to 750 nm) and therefore cannot be seen with the naked eye.

Is the Niris light harmful or require precautions, like some lasers?

No. The Niris Imaging System does not use a laser to supply the NIR (Near InfraRed) light at the System’s specified wavelength. Rather, it uses an effective alternative called a superluminescent diode (SLD) to produce continuous-wave low-coherence optical radiation. The Niris Imaging System has been demonstrated to be safe to the patient or the user from exposure to the emitted optical radiation.

Can the Niris Imaging System be used with endoscopes?

The Niris Probe is 2.7 mm in outer diameter and has a length of 2, 3, or 4 meters (m). The Probe’s small 8 Fr outer diameter enables the Probe to be inserted into the working channel of many flexible and rigid endoscopes. Contact your Imalux representative for further information regarding compatible endoscopes.

I’m not a radiologist; will I be able to interpret the images by myself or will I need a radiologist to assist?

The Niris Imaging System is intended to be used by the physician or medical personnel at the point-of-use. The user’s ability to efficiently review and interpret the Niris images depends on the user’s experience with the Niris Imaging System and images. There is a learning curve that a user should expect to go through, as the user gains an understanding of the tissue pathology and its relationship to the OCT image.

When obtaining multiple images during one procedure, how do I track the images to the tissue sites?

The Niris Imaging System software includes an image comment box for each image that may be used to record information regarding the specific tissue site of the image acquisition. A picture-in-picture arrangement can be set up with some additional (optional) hardware. When video cameras are being used, video recording of the P-I-P is easily added.

I might have an application for Niris OCT technology. Are you accepting new clinical sites?

We will work with you to ascertain whether the Niris system will help you meet your research objectives. Call us to discuss your needs and ideas at (866) OCT-NIRIS or (866) 628-6474) or email us at info@imalux.com.

 

The information provided on this website is for the purpose of educating potential users about the OCT technology.  Pictures contained on this website are for demonstration purposes only and should not be construed to accurately depict the body part, condition, or disease described.  Nothing contained on this website is intended to be instructional for medical diagnosis or treatment.  The information contained herein should not be considered complete, or take the place of thoroughly reading all inserts and labels pertaining to and included with the OCT technology.

Imalux shall not be liable for any improper use of the OCT technology and makes no representations or warranties as to the OCT technology’s efficacy, except as described in the labeling and inserts included with the product.  Imalux makes no representations or warranties as to the use of OCT technology in the event that the user attempts to service or repair the machine without using a technician certified by Imalux or uses any accessories other than those recommended by Imalux.

Caution: Federal law restricts this device to sale by or on the order of a physician.