MUSA is the world’s first surgical robot for open microsurgery. This robotic assistant is clinically and commercially available after the medical device CE-mark was issued by notified body DEKRA recently. Microsure’s MUSA is developed by a team of microsurgeons and engineers, creating a high-precision robotic assistant that is compatible with current operating techniques, workflow, instruments and other OR-equipment. It enhances surgical performance by stabilizing and scaling down the surgeon’s movements during complex microsurgical procedures on sub-millimeter scale.
Microsure’s MUSA e.g. enables lymphatic surgery on lymph vessels smaller than 0.3 mm in diameter. Plastic surgeons at Maastricht University Medical Center+ were the first to use MUSA to surgically treat lymphedema in a patient. This world’s premier super-microsurgical intervention with ‘robot hands’ took place in 2017. Maastricht University Medical Center+ is now conducting several follow up clinical research projects with MUSA, in different fields of microsurgery. Other European hospitals are expected to start clinical studies this year.
Surgical procedures that maximally benefit from Microsure’s MUSA are complex surgeries on small tissue structures –for instance LVA (Lymphovenous Anastomosis) surgery, pediatric vascalar surgery, free flap surgery, finger and hand replantation – when human precision is the limiting factor because of physiological tremor, poor accessibility or fatigue. Various studies and pilots have proven safe and effective clinical use of the device.
Microsure also received the ISO 13485 certificate, another major milestone. The ISO certification assures that Microsure is adhering to the highest standards in quality management and regulatory compliance procedures to develop, manufacture, and test its products and services. ISO 13485:2016 is the latest update to ISO requirements for a comprehensive quality management system for the design and manufacture of medical devices.