Microsure’s MUSA microchirurgische robot ontvangt CE-markering
EINDHOVEN, Nederland (BUSINESS WIRE) – MUSA is ‘s werelds eerste chirurgische robot voor open microchirurgie. Deze robotassistent is klinisch en commercieel beschikbaar nu de CE-markering van het medische hulpmiddel onlangs door de geautoriseerde instantie DEKRA is afgegeven. Microsure’s MUSA is ontwikkeld door een team van microchirurgen en ingenieurs, waardoor een uiterst precieze robotassistent is ontstaan die compatibel is met de huidige operatietechnieken, workflow, instrumenten en andere OK-apparatuur. Het verbetert de chirurgische prestaties door de bewegingen van de chirurg tijdens complexe microchirurgische ingrepen op sub-millimeterschaal te stabiliseren en in te korten.
Microsure’s MUSA Microsurgery Robot Receives CE-mark
EINDHOVEN, Netherlands–(BUSINESS WIRE)– 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.
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Surgeons using Microsure’s MUSA during a microsurgical procedure in a patient’s arm. Photo courtesy of Microsure.
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.
Microsurgery procedures with MUSA
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.
ISO 13485 certification
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.
Microsure
Microsure is a medical device company in Eindhoven (The Netherlands) founded by Eindhoven University of Technology and Maastricht University Medical Center in 2016, funded by Innovation Industries Fund. Microsure’s focus is to improve patients’ quality of life through developing robot systems for microsurgery. Its current product is MUSA, the world’s first surgical robot for open microsurgery. MUSA has been designed by microsurgeons and engineers, specifically for microsurgical applications. MUSA provides superhuman precision for microsurgeons, enabling new interventions that are currently impossible to perform by hand. www.microsure.nl
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Contacts
Microsure
Lars Schiemanck (CEO)
l.schiemanck@microsure.nl
+31 686 692 887