Safety, Efficacy and Patient Tolerance of the New 360º Cryoadipolysis Device for Multiple-Area Fat Removal

Abstract

Objectives: Cryoadipolysis is a non-invasive technique for complete body remodeling. It is a permanent fat reductionoption for patients with localized unwanted fat. Due to the unique advantages of the technology, it provides multiplebenefits compared to other options. The primary objective of this study is to compare the new Cooltech Define 360°applicators compared with the previous generation of Cooltech applicators. The secondary objective of this study is toevaluate the efficacy and safety of Cooltech Define.Methods: This study is divided into 2 parts. The first part compares the results achieved by the new 360° Cooltech Defineapplicators that reach -10°C versus the Cooltech applicators that reach -8°C. This prospective study involved 10 subjectsand 13 sessions. All subjects received a 70-minute procedure with both applicators and at the maximum suction level. Thesecond part of the study evaluates the efficacy of Cooltech Define on 23 subjects, A simultaneous multi-procedure wasperformed on up to 4 areas with different homogenous cooling applicators. All subjects received one session per area.Clinical data was well recorded with assessments completed before and after the procedure under evaluation using calipers, perimeter measurements and iconography. All potential side effects were also well documented.Results: In the first part of the study, the comparison shows that Cooltech Define provides greater comfort during theprocedure due to the design of the new applicator cup which allows the tissue to sit in the applicator without pulling onit strongly. The lower temperature induces hypoesthesia in the tissue more quickly. The sensation of pain from post-procedure massage and common side effects were higher than with Cooltech, especially for the evaluation of erythema andparesthesia or dysesthesia due to the more intense cooling. All subjects were able to return to daily activity without anynotable complaints. All side effects were self-limiting and resolved completely without long-term sequelae. In the secondpart of the study, the average skin fold change was -7.80 mm (±3.46 mm) while the average circumference change was-32.3 mm (±18.6 mm), with the highest results achieved being 20 mm and 80 mm respectively on subjects receiving up to4 simultaneous treatments. The results were shown in all treated areas for all applicators used on both genders.Conclusion: Both the Cooltech and Cooltech Define procedures based on cryoadipolysis technology provide safeand highly tolerated treatments for the reduction of localized fat, with minimal and reversible side effects. The newCooltech Define device has 4 applicators that can provide up to 4 simultaneous treatments in one session, it uses lowertemperatures and, thanks to the new applicator design, provides faster and homogenous cooling. It achieves superiorresults for localized unwanted fat reduction while also providing greater patient comfort. The results show the average skin fold change to be -7.80 mm (±3.46 mm) with a maximum change of 20 mm (50% reduction), and the averagecircumference change was -32.3 mm (±18.6 mm) with the highest result achieved in this study being 80 mm.