Evaluation of MUSA-3 in Microsurgical Anastomoses

Clinical Safety and Performance Evaluation of MUSA-3 in Microsurgical Anastomoses

This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.

Inclusion Criteria:

• Patient age ≥ 18 years.
• Patients requiring procedures involving micro-anastomosis of small anatomical structures-such as blood vessels, nerves, or lymphatic vessels-in free flap, lymphatic, or peripheral nerve surgery.
• Patients who have been selected by the research team at the Clinical Center as appropriate candidates for treatment with MUSA-3 in accordance with the IFU.
• Able to give informed consent before participating in the study.
• Provision of signed and dated informed consent form.

Exclusion Criteria:

• Subject participates in a potentially confounding drug or device trial during the course of the study.
• Patients that are pregnant or breastfeeding.

For Lymphedema patients:

• ≥ISL (International Society of Lymphology) Stage III lymphedema
• History of marcaine or indocyanine green allergy
• Non-viable lymphatic system as determined by ICG lymphatic mapping using near infrared camera