Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Inclusion Criteria: The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. * Ages 18 to 75 years (inclusive). * Swelling of 1 limb that is not completely reversed by elevation or compression * Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system * Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen * Willingness to maintain a stable regimen of self-care, with consistent use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration. * Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken. Affected limb volume ratio \>20% (affected limb compared to unaffected limb); volume measurements will be performed and volume ratio will be calculated at S1 and S2 visit. * Evidence of abnormal bioimpedance ratio, if feasible based upon unilate…