Motiva Flora® 

Revolutionizing Two-Stage
Breast Reconstruction

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

 

Implant image with text
Implant image with text

Port Locator

A noninvasive electronic device that interacts
exclusively with the Motiva Flora® Tissue Expander
to easily locate the expander’s integrated port and
enable accurate injection filling.7

 

 

 

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

Figure of a patient that underwent skin-sparing mastectomy
Figure of a patient that underwent skin-sparing mastectomy

Figure of a patient that underwent skin-sparing mastectomy with prepectoral implantation of Motiva Flora® SmootSilk® Tissue Expander. Extracted by Schiaffiano et al. 2023

Preoperative MR images
Preoperative MR images

(a,c); Preoperative MR images, (b,d); Images prior to planned exchange surgery to permanent implant demonstrating no effects on image quality with the Motiva Flora® SmoothSilk® Tissue Expander. T1 weighed panels (a,b); T2 weighed panels (c,d). Extracted by Schiaffiano et al.2023

MR Conditional

Data has 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).9,8

The Motiva Flora® SmoothSilk® Tissue Expander images at high field (3T).6

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. 8,6

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

Superior dosimetric breast x-ray
Superior dosimetric breast x-ray

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

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.8,11 

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.11

SmoothSilk® Surface

Landmark studies demonstrate surface advantages:4,5

  • 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.**

*Among those breast devices tested, smooth and textured. 

** When compared to textured surfaced breast devices.

 

REQUEST A DEMO

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. 

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. 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  
3. Establishment Labs®. DDD-001007: Device Description Motiva Flora® SmoothSilk® Tissue Expander. June 2023.  
4. 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  
5. 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  
6. 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.  
7. Establishment Labs®. DOC-038: Directions for Use for Motiva Flora Port Locator. August 2023.  
8. 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.
9. Establishment Labs®, Post-Market Surveillance Preliminary Results. Q1 2023.  
10. 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  
11. 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