AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.

This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).

Inclusion Criteria:

• Subject is female between the ages of 18-70
• Subject requires tissue expansion as part of breast reconstruction
• Subject is able to provide written informed consent
• Subject is able and willing to comply with all of the study requirements
• Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen

Exclusion Criteria:

• Subject's tissue integrity is unsuitable for tissue expansion
• Subject has residual gross malignancy at the intended expansion site
• Subject has current or prior infection at the intended expansion site
• Subject has a history of failed tissue expansion or breast reconstruction
• Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
• Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).