Industry Press Releases

Microsure obtains CE marking for its MUSA microsurgical robot

Monday, Jun 10, 2019

MUSA is the world's first surgical robot for open microsurgery. This robotic assistant is now available clinically and commercially after recently receiving the CE Mark of medical device by the notified body DEKRA. Microsure's MUSA is developed by a team of microsurgeons and engineers, who have created a high-precision robotic assistant that is compatible with modern operating techniques, workflows, instruments, and operating room equipment. It optimizes surgical performance by stabilizing and allowing the surgeon to perform sub-millimeter scale movements during microsurgical procedures.

The Microsure MUSA system allows, for example, lymphatic surgery on lymphatic vessels with a diameter of less than 0.3 mm. Plastic surgeons at Maastricht University Hospital were the first to use the MUSA system to surgically treat lymphedema in a patient. This first super microsurgical intervention in the world with "robotic hands" took place in 2017. The Maastricht University Hospital Center is currently performing several clinical follow-up studies on MUSA, in various fields of microsurgery. Other European hospitals are expected to launch clinical studies this year.

Microsurgery procedures with the MUSA device

Surgical procedures benefiting most from Microsure's MUSA system are complex interventions on small tissue structures (eg lymphovenous anastomosis (ALV), pediatric vascular surgery, flap surgery, reimplantation of fingers and hand) where human precision is the limiting factor due to physiological tremors, insufficient accessibility or fatigue. Various studies and pilot projects have demonstrated a safe and effective clinical use of the device.

ISO 13485 certification

In addition, Microsure has also achieved ISO 13485 certification. ISO certification ensures Microsure's adherence to the highest standards of quality management and regulatory compliance procedures for the development, manufacturing, and testing of its products and services. ISO 13485: 2016 is the latest update for the ISO requirements for a complete quality management system, from design to manufacture of medical devices.

Microsure

Microsure is a medical device company based in Eindhoven (The Netherlands), created by the Eindhoven University of Technology and the Maastricht University Medical Center in 2016, and funded by the Innovation Industries Fund. Microsure works to improve the quality of life of patients by developing robotic systems for microsurgery. Its MUSA system is the world's first surgical robot for open microsurgery. Designed by microsurgeons and engineers, MUSA specifically targets microsurgical applications. MUSA provides superhuman precision to microsurgeons, and allows new interventions that are currently impossible to achieve by hand. www.microsure.nl

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contacts
Microsure
Lars Schiemanck (CEO)
l.schiemanck@microsure.nl
+31 686 692 887

 

Source: businesswire.com

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