A window to the skin.

The VivaScope 1500 is the world‘s only confocal laser scan microscope for optical in-depth analysis of the human skin. Its maker has now placed manufacturing in the hands of technology partner WILD.

IInvasive. Sometimes painful. And often nerve-wracking due to long waiting times. Anyone who has had to have a suspicious mole checked is familiar with the challenges of a microscopic examination of excised tissue to detect pathological changes. Yet for some years now, there has been a proven alternative to this method: confocal laser scanning microscopy. This purely optical biopsy in real time is a journey ”into“ the skin, layer by layer. The skin‘s cellular microstructures can be depicted in horizontal, clearly defined ”optical cuts“ less than 5.0 μm thick, cell by cell. This imaging technique, which uses the tissue‘s different reflection properties, is applied in medicine both in vivo and ex vivo examinations. What is the advantage of this non-invasive view into the epidermis and dermis down to the upper reticular layer? It is pain-free, uncomplicated and quick.

This is true for both methods: With in vivo examination using confocal laser scanning microscopy, the patient is spared a painful and potentially unnecessary biopsy. The results of the examination are available after just a few minutes. Though a biopsy can be avoided in many cases as a result, ex vivo tissue sampling often remains indispensable. Here, too, confocal laser scanning microscopy can examine excised tissue with only a minimum of preparation. A quick evaluation of this tissue in horizontal, precisely defined optical cuts can be done immediately after excision. When carried out during surgery for excision margin control to differentiate between pathological and healthy tissue, such an analysis can render further surgery unnecessary.

According to VivaScope, currently more than 1,000 independent studies have established the overwhelming reliability and efficiency of this technology. A randomised clinical study in three Italian reference centres with 3,156 patients published in 2022 delivered the following results: ”As a result of the cellular resolution of VivaScope‘s technology, almost one in two lesions was found to be benign and thus did not require an excision.“ This corresponds to a reduction of unnecessary excisions by 43.4 percent. The use of confocal laser scanning microscopy has also proven effective in everyday practice. Numerous dermatological practices and clinics worldwide rely on VivaScope 1500 to deliver very short scanning times and a high resolution. As of late, the device is being manufactured by technology partner WILD. ”There were several reasons behind the decision to move production from the United States to us in Europe. At WILD, we were definitely an attractive option because of our optics expertise and our great experience in the industrial assembly of complex modules for medical technology. Moreover, our supply chain management and the development of a stable, scalable assembly process tipped the scales in our favour“, says Manfred Gallé, Head of Business Unit Medical Technology, pleased about the confidence shown by VivaScope.

This is also affirmed by VivaScope‘s Director for Sales & Marketing Giuseppe Solomita: ”As a result of its comprehensive optics and assembly expertise, WILD can offer constant and high quality on a permanent basis. Tumour analysis is a very serious matter. Therefore, we are committed to providing physicians with premium technology and the best image quality. We are convinced that WILD will exceed our

VivaScope assigned WILD the management of the complete product transfer. WILD handled this task using its proven Product Transfer Management System process, which ensures that all parameters are taken into account and that all experts from the areas of quality management, assembly, SCM and sales accompany the transfer from the very start. ”During this process, however, we also detected potential improvements, reviewed the assembly process to that effect, developed new equipment and introduced a new test process. All in all, we were able to guarantee a 100% stable product“, affirms WILD Project Manager Alexandra Roth. In addition, by having WILD as a manufacturing partner, VivaScope is now also capable of producing higher volumes and increasing its market presence accordingly. The company intends to develop future generations of its devices by resorting to WILD‘s optics expertise.

At any rate, the potential of these devices is significant. There are innumerable application and research areas in which confocal laser scanning microscopy can be used. This technology is particularly well-suited for screening examinations and for the diagnosis of skin cancer or early forms of skin cancer. Beyond dermatology, the technology is meanwhile used in seven ex-vivo applications, including urology and organ transplantation.

Moreover, it is employed in therapeutic monitoring, burns, dermatitis and inflammatory diseases, delivering an excellent comparability of images over time. This renders the VivaScope 1500 ideal for cosmetic and medical research. In addition, examinations using the VivaScope 1500 can be easily integrated in everyday practice. Its use could hardly be simpler, so that the images can be taken by qualified medical personnel. However, their interpretation is the responsibility of the attending dermatologist. Visit the COMPAMED/MEDICA 2023 and see for yourself how easy it is to use the VivaScope 1500. The medical device will be on display both at the VivaScope booth (Hall 10/H22) and the WILD Group booth (Hall 8a/J19).