The ongoing clinical study “Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm” has gained notable attention among regulatory, clinical, and quality professionals. Centered on addressing skin laxity, this research investigates the safety and performance of the Ultherapy Prime device—an innovative technology sponsored by The Levine Center for Plastic Surgery. Recruiting participants is now active, and the study explores the use of MFU-V (Microfocused Ultrasound with Visualization) at varying depths.
What changed?
The study marks a key development for aesthetic devices regulated under both safety and performance standards. The focus on skin laxity is a critical area of interest in medical aesthetics and dermatology, with new insights emerging surrounding MFU-V technology’s application at deeper tissue levels and its long-term efficacy. Recruitment is actively ongoing, offering an opportunity for eligible participants to contribute to defining device performance at multiple depths, including 1.5 mm.
How does Ultherapy Prime perform?
Ultherapy Prime employs MFU-V technology, which delivers precise ultrasound energy to targeted areas of the skin to stimulate collagen production. Known for its ability to treat skin laxity without surgery, the device focuses on stratified layers to address both immediate tightening needs and longer-term structural improvements. In clinical settings, MFU-V performed well, particularly in enhancing dermal support with non-invasive techniques. The present study validates these capabilities using methods adhering to Medical Device Regulation (MDR) Annex XIV standards.
What scientific evidence supports MFU-V?
Previous studies demonstrate that MFU-V technology can stimulate mechanical and biological processes in skin layers, enhancing elasticity and firmness. Device performance metrics often assess collagen remodeling timelines, depth effectiveness, and visual improvements documented by clinical teams.
What are the study goals?
The clinical trial primarily explores long-term efficacy, safety, and device performance. Investigators will evaluate outcomes like skin tightening durability and participant satisfaction. Specific measurements include the impact of energy delivery at a standardized depth of 1.5 mm as well as varying deeper depths. Clear evidence-based documentation supports transparency and ensures compliance with global regulatory frameworks.
Who are the stakeholders?
Stakeholders extend across clinical teams, regulatory professionals, and participants. For manufacturers and clinicians, the findings could influence product design, clearance documentation, and post-market surveillance strategies.
FAQ
- What conditions does the study focus on? The study focuses on skin laxity.
- What technology is under evaluation? Ultherapy Prime, using microfocused ultrasound with visualization (MFU-V).
- Where can participants apply? Recruitment is now active, but exact registration details are linked below.
- What are the device’s intended benefits? The intended benefits include improved skin elasticity, tightening, and long-term enhancement of collagen production.
- What oversight governs the study? The study complies with regulatory expectations documented under MDR and is overseen by clinical and sponsor-driven protocols.
Conclusion
The active recruitment for Ultherapy Prime-backed research opens new opportunities to test the efficacy limits of MFU-V applications. Industry stakeholders should monitor emerging findings and leverage data for advancements in skin laxity treatments. Collaboration between manufacturers and clinical teams ensures ongoing compliance and innovative outcomes rooted in evidence-based practice.
Disclaimer
This article is intended for informational use by clinical, quality, and regulatory professionals. It does not constitute legal or medical advice.
Official announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07224308?term=medical+device