FixNip Ltd
This is a prospective, single center, controlled, open-label feasibility IDE clinical study enrolling patients with a history of breast cancer who have previously undergone total mastectomy with breast reconstruction and are seeking nipple reconstruction.
Inclusion Criteria: * Female Subject age 22 years or older * Subject of childbearing potential must agree to use medically accepted methods of contraception throughout the study and have a negative pregnancy test at screening * History of breast cancer treated with total mastectomy only, with implant-based or autologous breast reconstruction seeking reconstruction of the nipple-areolar complex. * Local tissue thickness at the intended nipple location of at least 10 mm, confirmed by both pinch test and ultrasound-based assessment. Tissue thickness requirement must extend across the entire impl…
NRI implantation
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