PRIMO Post-Market Clinical Follow Up Study

PMCF study aimed to monitor the safety, usability, performance and long-term efficacy of Symani. Furthermore, it will permit to detect potential emerging risks related to safety on the basis of clinical evidence through the observation of patients who have undergone microsurgical reconstructions using the Symani Surgical System in the usual setting of standard surgical practice.

Inclusion criteria

• Male and female patients aged >18
• Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a post-oncological, post-traumatic or congenital tissue defect or to treat lymphedema.
• Patients who have been selected by the PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
• Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantation, lymphatic reconstructions.
• Subjects who agree to have the surgery and the anaesthesia.
• Subjects who voluntarily decide to participate in this study with the surgery performed with the aid of the Symani System and sign the Informed Consent Form.

Exclusion criteria

• Subjects who have bleeding or coagulation disorders in the past or present.
• Any criteria that preclude prolonged anesthesia.
• History of anaphylaxis or severe complicated allergy symptoms.
• Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
• Evidence or history of autoimmune disease or compromised immune system.
• Participation in another clinical trial within 4 weeks prior to participation in the study.
• Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
• Subjects with pacemaker