LN Robotics' 'Vascular Intervention Procedure Robot', First Approval by MFDS in Korea

[Asia Economy Reporter Chunhee Lee] L&Robotics announced on the 17th that it has obtained the Ministry of Food and Drug Safety's product approval for the first time in Korea for a robot assisting coronary artery intervention.

The approved robot is a vascular interventional procedure robot that assists coronary angiography and intervention. It was developed after about three years of functional improvement and supplementation following the successful first exploratory clinical trial conducted at Seoul Asan Medical Center under MFDS approval in October 2019.

Coronary artery intervention is commonly called "stent (metal mesh) insertion." It is a procedure in which a thin, long wire is used to access the heart vessels, then the blocked or narrowed vessels are widened by balloon angioplasty, and a stent metal mesh is inserted to support the vessel, allowing blood to flow smoothly. Due to the diversity and complexity of lesions in vascular diseases, extensive experience and skill of the operator are required.

L&Robotics explained that its cardiovascular interventional procedure robot implements differentiated technologies such as precise control and haptic technology that express the movements of skilled operators through the robotic system, and multi-channel surgical tool control technology capable of responding to complex procedures.

Using the robot enables various clinical applications such as remote interventional procedures for emergency patients and non-face-to-face interventional procedures that can respond to infectious situations, and it can minimize medical staff's radiation exposure during interventional procedures.

L&Robotics was founded in 2019 by Professor Choi Jae-soon of the Medical Engineering Research Institute at Seoul Asan Medical Center and Professor Kim Young-hak of the Cardiology Department at Seoul Asan Medical Center. This product was developed through an accelerated corporate collaboration development platform based on clinical field results from the research-oriented hospital fostering project led by Seoul Asan Medical Center.

Choi Jae-soon, CEO of L&Robotics, said, "The Ministry of Food and Drug Safety's precise product analysis and provision of approval guidelines were the greatest foundation for obtaining this product approval," adding, "We will accelerate our efforts to achieve another global leading medical robot company with our own hands." Professor Kim Young-hak, who leads clinical development, also said, "We will advance to a more sophisticated product through various clinical validations," and evaluated, "It is a very encouraging milestone that Korean cardiologists, who are at the global leading level, can plan the first steps in next-generation robotic procedures with our own technology without relying on overseas technology."