Microfocused ultrasound with visualization: Consensus on safety and review of energy-based devices.

BACKGROUND: Microfocused ultrasound with visualization (MFU-V; Ultherapy® , Merz North America) is US Food and Drug Administration-cleared as a non-invasive procedure that lifts the soft tissue of the neck, submentum and brow, and improves lines and wrinkles on the upper chest. Several other energy-based devices are in use in countries outside the USA where they are marketed for indications similar to those of MFU-V, although published studies supporting these indications are limited and none of the other devices provides visualization or verification they reach the superficial musculoaponeurotic system. METHODS: Due to the evolving landscape of ultrasound technology as more devices enter the market, seven global thought leaders who are qualified experts on the use of various high-intensity focused ultrasound (HIFU)/MFU-V technologies convened to review data from an independent evaluation of the software, thermal characteristics, transducer acoustics and ultrasound therapy of MFU-V and three other ultrasound-based devices. RESULTS: The independent testing demonstrated the devices have key differences in several parameters that play a role in safety and effectiveness. Specifically, MFU-V has visualization capability but the other devices lack that feature. Other differences include the retention of patient history, consistent size and uniformity of thermal coagulation points (TCPs), precise localization of energy concentration at the focal point, and reliable thermal regulation during use. The expert panel established a consensus on the types of preventable complications associated with ultrasound-based energy devices and techniques for preventing and treating complications. CONCLUSIONS: The independent test results of MFU-V/HIFU devices and the consensus panel conclusions provide strong support that real-time visualization and the capability to detect coupling, features found only in MFU-V, help prevent complications and enhance the safety and effectiveness of energy-based devices. The independent evaluation also revealed that MFU-V has several additional features that play key roles in safety and clinical effectiveness, including uniformity of TCPs, tight thermal regulation, large focal gain, and short beam length, that were not found collectively in any of the HIFU devices.

IncobotulinumtoxinA in aesthetics: Russian multidisciplinary expert consensus recommendations.

BACKGROUND: Although there are various international consensus recommendations on the use of botulinum neurotoxin type A (BoNT/A) in facial aesthetics, there are no global or Russian guidelines on the optimal dose of incobotulinumtoxinA, free from complexing proteins, within specific aesthetic indications. This article reports the outcomes of two expert consensus meetings, conducted to review and analyze efficacy and tolerability data for incobotulinumtoxinA in various facial aesthetic indications and to give expert consensus recommendations to ensure best clinical practice among Russian clinicians. METHODS: Thirteen dermatology and/or plastic surgery experts attended meetings held in Paris, France (November 2013), and Moscow, Russia (March 2014). The expert group reviewed and analyzed the existing evidence, consensus recommendations, and Russian experts' extensive practical experience of incobotulinumtoxinA in aesthetics to reach consensus on optimal doses, potential dose adjustments, and injection sites of incobotulinumtoxinA for facial aesthetics. RESULTS: All experts developed guidance on the optimal doses for incobotulinumtoxinA treatment of different regions of the upper and lower face. The expert panel agreed that there are no differences in the efficacy and duration of the effect between the four BoNT/As that are commercially available for facial aesthetic indications in Russia and that, when administered correctly, all BoNT/As can achieve optimal results. Experts also agreed that nonresponse to BoNT/A can be caused by neutralizing antibodies. CONCLUSION: On the basis of the scientific and clinical evidence available for incobotulinumtoxinA, coupled with the extensive clinical experience of the consensus group, experts recommended the optimal doses of incobotulinumtoxinA effective for treatment of wrinkles of the upper and lower face to achieve the expected aesthetic outcome. These first Russian guidelines on the optimal use of incobotulinumtoxinA for augmentation of glabellar lines, periorbital wrinkles, forehead lines, bunny lines, perioral wrinkles, depressor anguli oris, mentalis, masseters and platysmal bands, and performing the Nefertiti lift, are presented here.