Therapeutic Focus: Devices

Growth Predicted in Dermatology Device Market

A new report, “Dermatology Devices Market by Diagnostic Device (Imaging Device, Dermatoscope, Microscope), Treatment Device (Electrosurgical, Cryotherapy, Laser), Application (Skin Cancer Diagnosis, Acne, Psoriasis, Skin Rejuvenation, Warts) - Global Forecasts to 2021”, provides a detailed overview of the major drivers, restraints, challenges, opportunities, current market trends, and strategies impacting the dermatology devices market, along with revenue estimates forecasts and market share analysis.

The global dermatology devices market is expected to reach $14.17 Billion by 2021 from $8.22 Billion in 2016, at a CAGR of 11.50% during the forecast period. The rising incidence of skin disorders, increasing awareness on aesthetic procedures, technological advancements, and increasing healthcare expenditure are the major factors driving the growth of this market.

The global dermatology devices market is segmented into diagnostic devices (by type and application) and treatment devices (by type and application).

FDA Clears Syneron Candela’s Profound SubQ to Improve Cellulite

In late 2016, Syneron Candela received FDA 510(k) clearance for Profound when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as supported by long term data (6 months).

Watch it Now

Eye Safety: Avoiding and Managing Complications
Wendy Lee, MD and Jason Bloom, MD discuss how to avoid complications, protect the eye, and get the best outcomes with noninvasive periocular rejuvenation. In Modern Aesthetics Journal Club, from Practical Dermatology® magazine’s sister publication Modern Aesthetics,® Dr. Lee reviews danger zones and stresses the importance of knowing the anatomy, being conservative, and following safety protocols when injecting or using lasers or lights around the eyes.

A recent multi-center clinical study of Profound showed improvement of cellulite severity (in dimples and/undulation irregularities) in 94 percet of treated thighs assessed at a three month follow up by blinded review. Sustained improvement was observed at six month follow up in 93 percent of the treated thighs. When considering improvement in each cellulite feature separately, 86 percent of the treated thighs (of the 80 thighs with dimples at baseline) showed improvement in dimples, and 76 percent of the thighs (all thighs had undulation at baseline) showed improvement in undulation irregularities. Per subject results were similar, where 88 percent of the treated subjects showed improvement in the appearance of cellulite in both thighs in dimples and/or undulation at 3 months follow up, and 86 percent of the treated subjects showed improvement at 6 months follow up.

“There has been an increased demand for treatments that can impact the appearance of cellulite over the past few years as it’s a driver of insecurities in both men and women,” said Macrene Alexiades, MD, PhD, Associate Clinical Professor, Yale University School of Medicine, and Director President of Dermatology Laser Surgery Center of New York. “Profound is an optimal treatment for patients with cellulite who are apprehensive about invasive procedures, as well as for those who are looking to improve the appearance of areas impacted by cellulite in a single treatment. Some subjects showed improvement starting at one month after treatment.”

FDA clearance for Profound to improve the appearance of cellulite using the SubQ cartridge and handpiece is based on positive data from utilizing the device in an institutional review board (IRB) reviewed multi-center study. Syneron Candela plans to release the product in 2017.

Next-Generation Vanquish ME Device from BTL Reduces 53% More Fat

Results of a new clinical evaluation from BTL Aesthetics show that its BTL Vanquish ME device was effectively redesigned for more efficient, predictable, and homogenous energy delivery to the targeted tissue. The results showed ignificantly better outcomes in abdominal fat thickness reduction, 53% higher, with BTL Vanquish ME versus BTL Vanquish.

The multi-center study, conducted by Drs. Nicole Hayre, Peter Jenkin and Melanie Palm, sought to compare clinical outcomes of the noninvasive selective radiofrequency (RF) field device BTL Vanquish ME with its predecessor. A total of 36 subjects with BMIs under 30 but above 24, were randomly assigned to be treated in Group A (BTL Vanquish ME) or Group B (Vanquish) to obtain a side-by-side comparison of the devices’ efficacies. Each subject received four, once-weekly, 45-minute treatments with their group’s determined device. Measurements of subjects’ abdominal fat were taken prior to the first treatment and again four weeks after finishing the final treatment. Subjects had also been instructed to maintain their usual diet and lifestyle throughout the duration of the study.

Abdominal fat layer thickness reduction at 30 days post treatment was the primary outcome measurement in the study as measured by ultrasound. The degree in fat layer thickness between Group A and B was statistically significant (p0.008), and data showed that fat for Group A (BTL Vanquish ME) and Group B (BTL Vanquish) was reduced by 29.5% and 15.2%, respectively. That represents a 53% higher reduction of abdominal fat layer thickness with Group A than for those in Group B. Every subject in the study showed a reduction in the abdominal fat layer thickness.

• Group A: Reduction average of 4.17 ±1.42 mm
• Group B: Reduction average of 2.72 ± 2.21 mm

The standard deviation of ultrasound measurements in Groups A and B were 1.42 mm and 2.21 mm, respectively—and this reduction in standard deviation of fat reduction measurements in Group A vs Group B is evidence that the BTL Vanquish ME™ provides more consistent performance.

Finally, using the measured reduction in fat layer thickness and the treatment surface area of the applicator (2100 cm2 or 325.5 square inches), a reduction of 0.876 liter (0.23 liquid gallon) and 0.571 liter (0.15 liquid gallon) of fat were calculated for Groups A and B, respectively.

The BTL Vanquish ME device holds three patents: One, granted in 2013, protects the non-contact method of adipose tissue treatment. The second, issued in September 2016, is for the feedback power control device for non-invasive treatment of skin and human tissue. The third—issued in October—refers to a new method for treating subcutaneous tissue that positions one or more applicators adjacent to the skin of a patient, but not touching the skin or in need of continual movement by the applicator. These applicators, which transmit electromagnetic energy into the skin where it can be used for subcutaneous tissue treatment, may also be used for tightening the skin and for remodeling collagen tissue in the subcutaneous tissue.