Motiva Flora

 

Revolutionizing
Two-Stage Breast Reconstruction

Motiva Flora® SmoothSilk® Tissue Expander is the first and only single-port, magnet-free and MR Conditional breast tissue expander in the US.

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Port Locator

A noninvasive electronic medical device that interacts exclusively with the Motiva Flora® SmoothSilk® Tissue Expander to easily locate the expander’s integrated port and enable accurate injection filling.12

Demonstrated MR Conditional Use

Clinical studies have shown that the Motiva Flora® SmoothSilk® Tissue Expander has no known hazards in specific MR environments with conditions of use (1.5, and 3 Tesla MR systems).2,3 


The Motiva Flora® SmoothSilk® Tissue Expander images at high field (3T).3 


Under the specific MR conditions per labeling, the Motiva Flora® SmoothSilk® Tissue Expander demonstrated no MR-related complications such as discomfort related due to expander displacement, overheating reported, or MR damage to the expander port.2,3

MRI with Motiva Flora® SmoothSilk® Tissue Expander with RFID Port

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Motiva Flora® SmoothSilk® Tissue Expanders with the RFID port do not generate distortion of T1 (a) or T2 (b) in weighted axial MRI images*.

MRI with Traditional Magnetic Port

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Traditional magnetic ports create large distortions that impede correct assessment of T1 (a) and T2 (b) in weighted axial MRI images, even in the contralateral breast*.

 

*Reprinted with authorization: Roller R, Chetlen A, Kasales C. J Am Osteopath Coll Radiol. 2014;3(1):2-9. AOCR

Superior Dosimetric Results

The RFID port technology reduces the artifact on CT imaging due to a lower radio density in comparison to metals in conventional expander ports.12,13

During radiotherapy treatment planning, the Motiva Flora® SmoothSilk® Tissue Expander has shown superior dosimetric results for doses to the heart and lungs in comparison to traditional metallic port expanders, reducing the potential clinical toxicity to these vital organs.13

 

 

 

 

CT images with Motiva Flora® SmoothSilk® Tissue Expanded and a Traditional Magnet Port

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An example of the CT image (a) RFID port, (b) metallic port analysis using five reference points; a: central chest wall (blue), b: medial chest wall (green), c: lateral chest wall (yellow), d: axilla (red) and e: left anterior descending artery (brown). Extracted from Hwang et al. 2021

SmoothSilk® Surface

Landmark studies demonstrate surface advantages:6,15

  • Significantly lower capsular thickness*

    Reduced fibrotic markers in ultrasound and histological analysis.

  • A unique immune infiltrate in the capsule

    The lowest level of immune activators and a balanced presence of regulatory cells.*

  • Reduced expression of inflammatory cytokines and higher presence of anti-inflammatory cytokines.*

    Significant decrease of pro-inflammatory cells, compared with textured surface devices.

  • Significantly reduced periprosthetic fluid around the Motiva Flora® SmoothSilk® Tissue Expander.**

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*Among those breast devices tested, smooth and textured. 
** When compared to textured surfaced breast devices.

Motiva Flora® SmoothSilk® Tissue Expanders are intended for temporary (less than six months) subcutaneous or sub muscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

References

1. Bletsis P, Bouwer L, Ultee K, Cromheecke M, van der Lei B. Evaluation of anatomical and round breast implant aesthetics and preferences in Dutch young lay and plastic surgeon cohort. J Plast Reconstr Aesthet Surg. 2018. 71(8), 1116-1122. doi: 10.1016/j.bjps.2018.04.010 
2. Bayasgalan M, Munhoz AM, Shellock FG. Breast Tissue Expander With Radiofrequency Identification Port: Assessment of MRI Issues. American Journal of Roentgenology, 2020. 215(1), pp.159–164. doi:https://doi.org/10.2214/ajr.19.22492. 
3. Schiaffino S, Cozzi A, Pompei B, Scarano AL, Catanese C, Catic A, Rossi L, Del Grande F, Harder Y. MRI-Conditional Breast Tissue Expander: First In-Human Multi-Case Assessment of MRI-Related Complications and Image Quality. J Clin Med. 2023 Jun 30;12(13):4410. doi: 10.3390/jcm12134410. 
4. Khavanin N, Gust MJ, Grant DW, Nguyen KT, Kim JYS. Tabbed tissue expanders improve breast symmetry scores in breast reconstruction. Arch Plast Surg. 2014;41(1):57-62.doi:10.5999/aps.2014.41.1.57 
5. Establishment Labs®. DDD-001007: Device Description Motiva Flora® SmoothSilk® Tissue Expander. Data on File. 
6. Doloff JC, Veiseh O, de Mezerville R, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits, and humans. Nat Biomed Eng. 2021;5(10):1115-1130. doi:10.1038/s41551-021-00739-4 
7. Rosas JM, Atkins DJ, Chau AL, et al. In vitro models of soft tissue damage by implant-associated frictional shear stresses. Proceedings of the Institution of Mechanical Engineers, Part J: Journal of Engineering Tribology. 2022;0(0). doi:10.1177/13506501221132897 
8. Jones P, Mempin M, Hu H, et al. The functional influence of breast implant outer shell morphology on bacterial attachment and growth. Plast Reconstr Surg. 2018;142(4):837- 849. doi: 10.1097/PRS.0000000000004801 
9. James G, Boegli L, Hancock J et al. Bacterial Adhesion and Biofilm Formation on Textured Breast Implant Shell Materials. Aesth Plast Surg. 2019 Apr; 43:490–497. doi: 
10.1007/s00266-018-1234-7 10. Aitzetmuller-Kleitz ML, Yang S, Wiebinghaus P, Wellenbrock S, Ozturk M, Kuckelhaus M et al. Complication rates after breast surgery with the Motiva Smooth SilkSurface silicone gel implants – A systematic review and meta-analysis. Clin. Med. 2023, 12,1881. doi: 10.3390/jcm12051881 
11. Establishment Labs Holdings Corp. Establishment Labs Notes Presentation of 4-Year Results from Motiva U.S. IDE Study at The Aesthetic Meeting 2024. https:// investors.establishmentlabs.com/press-releases/ pressreleasesdetails/2024/Establishment-Labs-NotesPresentation-of-4-Year-Results-from-Motiva-U.S.- IDEStudy-at-The-Aesthetic-Meeting-2024/default.aspx. Published May 2nd, 2024. Accessed May 28th, 2024. 
12. Establishment Labs®. DOC-038: Directions for Use for Motiva Flora Port Locator. Data on File. 
13. Hwang NH, Kim M, Lee NK, Lee S, Hwang J. Dosimetric effect of injection ports in tissue expanders on post-mastectomy volumetric modulated arc therapy (VMAT) planning for left-sided breast cancer. Applied Sciences. 2022, 12 (13), 6461. doi:10.3390/app12136461 
14. Clausen-Oreamuno C, Perez-Rodrigo S, Stillaert F, Tejerina A, Tejerina A, Shellock F. Benefits of Using Magnetic Resonance Imaging During Breast Tissue Expansion: Literature Review and Case Series, Aesth Surg Jour, 2023; sjad264, doi.org/10.1093/asj/sjad264 
15. Schoberleitner I, Augustin A, Egle D, et al. Is It All about Surface Topography? An Intra-Individual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction. J. Clin. Med. 2023, 12, 1315. https:// doi.org/10.3390/jcm12041315

Motiva®, Establishment Labs®, Aesthetic BreastRecon®, Motiva Flora®, SmoothSilk®, and TrueFixation® are trademarks of Establishment Labs Holdings® Inc.