This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Mount Hospital
Subiaco, Western Australia, Australia
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Time frame: 6 months
Adverse Events related to the Breast Reconstruction Procedure
Time frame: 6 months
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