In vivo histological evaluation of non-insulated microneedle radiofrequency applicator with novel fractionated pulse mode.

INTRODUCTION: Microneedle radiofrequency is a novel method that allows non-thermal penetration of the epidermis followed by RF coagulation in selected depth of the dermis surrounded by zone of non-coagulative volumetric heating. The first generation of Microneedle RF applicators used insulated needles. These treatments were limited by a few factors, including low volume of dermal heating, lack of effect in the papillary dermis and pinpoint bleeding during the treatment. The system tested in this study (EndyMed PRO, Intensif applicator, EndyMed Medical, Cesarea, Israel) utilizes special extra sharp tapered non-insulated microneedles and a special pulse mode, allowing full coagulation during treatment and higher effective volume of dermal heat. METHODS: After Ethics Committee approval, one female pig (Type Large white X Landrace, 34 Kg) was chosen for the study. The animal was anesthetized using Ketamine, Xylazin and Isofluran. The EndyMed PRO, Intensif applicator (was used for treatment with different needle depth penetration (1 mm-3.5 mm) and in multiple energy settings. Six mm punch biopsies were harvested for histological analysis at the following time points: immediately after the treatment, 4 days after the treatment and 14 days after the treatment. H&E and Masson-Trichrome stains were processed. RESULTS: Visual inspection of the treated skin, immediately after the treatment, revealed arrays of pinpoint erythematous papules surrounded by undamaged epidermal tissue. Treatment field showed no sign of bleeding. Mild to moderate Erythema and Edema developed a few minutes after the treatment, varying according to the total energy delivered. The histologies taken 4-day after therapy showed in all energy settings, dry micro crusts over the treatment zones, with full healing of epidermis. In the 14-day specimens there was a replacement of the crusts/debris by a normal looking stratum corneum with complete healing of epidermis and dermis. DISCUSSION: The current in vivo study confirms that the EndyMed PRO Intensif applicator effective and predictable tool to create cylindrical micro zones of coagulation in the papillary and reticular dermis with minimal damage to the epidermis. The histologies taken 4 days and 14 days after treatment show rapid epidermal renewal with predictable volume of coagulation in dermis related to the length of the needle and the power used. Coagulation of capillaries during treatment allows a dry treatment field. The predictability of the effect and minimal downtime may offer a significant advantage over treatments with ablative fractional lasers of insulated RF microneedles.

In vivo animal histology and clinical evaluation of multisource fractional radiofrequency skin resurfacing (FSR) applicator.

OBJECTIVE: Acne scars are one of the most difficult disorders to treat in dermatology. The optimal treatment system will provide minimal downtime resurfacing for the epidermis and non-ablative deep volumetric heating for collagen remodeling in the dermis. A novel therapy system (EndyMed Ltd., Cesarea, Israel) uses phase-controlled multi-source radiofrequency (RF) to provide simultaneous one pulse microfractional resurfacing with simultaneous volumetric skin tightening. METHODS: The study included 26 subjects (Fitzpatrick's skin type 2-5) with moderate to severe wrinkles and 4 subjects with depressed acne scars. Treatment was repeated each month up to a total of three treatment sessions. Patients' photographs were graded according to accepted scales by two uninvolved blinded evaluators. RESULTS: Significant reduction in the depth of wrinkles and acne scars was noted 4 weeks after therapy with further improvement at the 3-month follow-up. CONCLUSION: Our data show the histological impact and clinical beneficial effects of simultaneous RF fractional microablation and volumetric deep dermal heating for the treatment of wrinkles and acne scars.