Optimizing Patient Outcomes by Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard Consensus Guidelines from an Expert Panel

Background: Microfocused ultrasound with visualization (MFU-V) has emerged as a safe and reliable means for lifting and tightening lax skin. Although patients may present with similar age-related changes in the skin and connective tissue, MFU-V treatment must be customized for each patient. Objective: The following guidelines were prepared to provide a framework for clinicians to develop a customized treatment plan based on the proper use of ultrasound imaging and key patient characteristics to achieve good clinical outcomes with MFU-V. Methods and Materials: A panel of five expert aesthetic physicians convened to discuss recommendations on the use of MFU-V. Topics included patient factors contributing to favorable outcomes; customizing the number of treatment lines, energy settings, and treatment depths; approaches for restorative vs preventative vs maintenance treatments; and important safety considerations. Results: Ultrasound imaging is important for selecting transducers and treatment depth and planning the number of treatment lines at each depth. Ideal outcomes are associated with higher density treatments. Treatment intervals are tailored to age, with older patients requiring more frequent treatments to maintain results. MFU-V can be applied for both preventative and restorative treatments. Managing patient expectations is essential. Conclusion: Supported by a large body of clinical evidence, a well-characterized mechanism of action, and high patient satisfaction, MFU-V is considered by the expert panel of physicians to be a key foundation of aesthetic treatment and the gold standard for nonsurgical lifting and skin tightening.

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.