Advancing women's health with a pioneering implant to treat breast cancer related lymphedema.

Abstract

Lymphedema (LE) is a globally recognized chronic and disabling condition with a high prevalence. At present, there is no curative treatment for LE, and management options are primarily limited to conservative approaches. To address this unmet need, we developed an innovative implantable device - the first-of-its-kind designed to replicate the function of lymphatic vessels in the affected limb. This novel device utilizes subcutaneous catheters and a micropump system to actively manage lymphatic fluid, representing a significant departure from traditional treatments. To evaluate feasibility, preliminary safety, and efficacy of this novel device, we conducted the first-in-human pilot study LymphoPilot. Nine patients with unilateral breast cancer-related LE (BCRL) underwent implantation of the device and discontinued conventional LE treatment. The device remained implanted for 8 weeks, during which its safety and efficacy were assessed. Results demonstrated no safety concerns and showed significant reductions in limb volume without the need for manual lymphatic drainage or compression treatment. These promising findings highlight the potential of this innovative approach and emphasize the need for further research into its long-term use as an alternative to current LE management strategies. This pioneering development offers hope for a transformative shift in LE treatment.