This study is a first in human, two-stage single arm non-comparative study of safety and performance.
The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.
Female patient over 18 Years old
Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
Breast reconstruction after unilateral preventive total mastectomy
or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation
Positive or suspicious extemporaneous sentinel node biopsy
Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment
Quanta Medical
Lead sponsor
Lattice Medical
Collaborator