Michael Barbella, Managing Editor01.05.24
Microbot Medical Inc. is touting successful initial outcomes for its LIBERTY Robotic Surgical System in a pivotal pre-clinical study.
The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach 48 animal targets. Six LIBERTY Systems were used in the study, and each was used to reach eight targets. All six LIBERTY Systems performed flawlessly, with 100% usability and technical success, according to the company. No acute adverse events or complications were visually observed intra-operative.
Subject to a final report and completion of the verification and validation (V&V) process, the company plans to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration in order to start a human clinical trial. The LIBERTY Robotic Surgical System aims to improve the way surgical robotics are currently being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company claims the LIBERTY Robotic Surgical System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.
"We are extremely pleased with the LIBERTY system performance during the pivotal pre-clinical study, both from the usability and technical outcomes as well as the lack of visual acute intraoperative complications. The system operated without any issues in all cases, achieving our initial objectives for the study," Microbot Medical Chief Technology Officer/General Manager Simon Sharon said. "We are continuing to take all necessary steps towards submitting our IDE application to the FDA and commencing our pivotal clinical trial."
Microbot Medical Inc. is a pre-clinical medical device company that specializes in transformational micro-robotic technologies. It aims to improve clinical outcomes for patients and increase accessibility through the human body's natural and artificial lumens.
The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach 48 animal targets. Six LIBERTY Systems were used in the study, and each was used to reach eight targets. All six LIBERTY Systems performed flawlessly, with 100% usability and technical success, according to the company. No acute adverse events or complications were visually observed intra-operative.
Subject to a final report and completion of the verification and validation (V&V) process, the company plans to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration in order to start a human clinical trial. The LIBERTY Robotic Surgical System aims to improve the way surgical robotics are currently being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company claims the LIBERTY Robotic Surgical System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.
"We are extremely pleased with the LIBERTY system performance during the pivotal pre-clinical study, both from the usability and technical outcomes as well as the lack of visual acute intraoperative complications. The system operated without any issues in all cases, achieving our initial objectives for the study," Microbot Medical Chief Technology Officer/General Manager Simon Sharon said. "We are continuing to take all necessary steps towards submitting our IDE application to the FDA and commencing our pivotal clinical trial."
Microbot Medical Inc. is a pre-clinical medical device company that specializes in transformational micro-robotic technologies. It aims to improve clinical outcomes for patients and increase accessibility through the human body's natural and artificial lumens.