Preceyes B.V. has received CE marking approval for its PRECEYES Surgical System R1.1 to assist trained surgeons during vitreoretinal surgical tasks in patients requiring vitreoretinal intervention under local or general anesthesia. The use of the robotic assistant is anticipated to not only improve treatment quality to be provided to patients, it also offers the possibility of developing completely new treatments.
Preceyes receives CE Marking approval for its eye surgery robot
The PRECEYES Surgical System R1.1 is the world’s first robot that has been clinically validated to assist surgeons in retinal surgery. With the CE mark, the robotic system is now available for wider commercial deployment in Europe and can be readily integrated at major hospitals and institutes for clinical and research activities. The system has a proprietary design and is developed in collaboration with clinicians to user requirements.
The robotic manipulator of the PRECEYES Surgical System holds and positions a surgical instrument inside the eye. The system allows surgeons to operate on retinal structures down to as little as 20 microns in size for prolonged periods of time, compared to the standard physiological limit of 100 microns for manual surgery. Furthermore, the system is able to automate motion profiles, including limiting instrument movement. Surgeons cannot offer this type of high-precision surgery to their patients with manual surgery.
“Retinal surgeries demand a high degree of precision and steadiness,” said Prof. Marc de Smet M.D., Chief Medical Officer of Preceyes. “The precision of our robotic assistance will enable better treatment quality as well as the possibility to develop new treatments. It represents the most advanced option in eye care available to date. While we are focusing on vitreoretinal applications at the moment, we believe the system can be developed to assist surgeons in performing most surgical procedures in the eye.”
Gerrit Naus, Chief Executive Officer of Preceyes said: “This CE mark is the first approval by a regulatory agency for the use of a robotic system in retinal surgery and confirms our position as the world leader in robot-assisted retinal eye surgery. The CE marking approval is an important milestone for Preceyes. We will leverage the CE marking approval for further industrialization of our technology and commercial deployment in Europe, developing partnerships for accessing markets worldwide.”
For more information on the PRECEYES Surgical System, visit www.preceyes.nl.