Swiss medical technology company AOT has obtained CE certification for what it says is the “world’s first human-approved contact-free laser cutting of bones with a robot”.
The patented Cold Ablation Robot-guided Laser Osteotome system – CARLO for short – is said to cut bones precisely and contact-free with a specialized laser using a robot.
The laser beam vaporizes the water inside the bone substrate within milliseconds, so the bone will be removed precisely in layers, leaving no residue, as deep as desired or until it is severed.
New cutting forms enable previously unachievable functional geometries for patient-specific, precisely fitting requirements. The laserhead mounted on a tactile robotic arm is controlled by a navigation system.
Safety for patients and staff is the highest priority for CARLO. Every movement of the patient or change of the operation set-up lead to immediate termination and the laser head refocusses itself automatically till the correct position is reached again.
This ensures automatic readjustment of any changes from a safe distance without patient contact. No tools need to be removed from the operating area; no drill or saw blade can bend, break-off and harm the patient.
The pre-operative plan of the bone incision, already electronically created today, is passed on to the robot for autonomous execution without media discontinuity. An important step towards a continuous digitization process in surgical interventions.
Assistant Professor Gabriele Millesi, president of the International Association of Oral and Maxillofacial Surgery (IAOMS), says: “As a team of maxillofacial surgery at the Medical University of Vienna, it was very important and an honor for us to participate in an impressive chapter of innovative intraoperative surgical technology.
“We were able to use the CARLO technology with success and conviction on patients with skeletal dysgnathias (malposition of jaw) of various degrees of severity, with very satisfactory results for us as surgeons as well as for our patients.
“The future of the CARLO will be determined in the high precision and the individually designable cutting trajectories. The successful first-in-man study is a door-opener.”
Cyrill Bätscher, CEO of AOT, says: “The CE certification after years of intensive development is an important milestone. We have demonstrated the enormous potential of contact-free, robot-assisted surgery based on our laser technology for cutting bones.
“We have thus come a huge step closer to our vision of elevating classic surgical tools to the next level with our latest technology for the benefit of patients.”
Dr Erich Platzer, chairman of the board and business angel investor since the beginning, says: “AOT still has big plans.
“CARLO is now CE-certified for applications in CMF surgery – our focus is now on medical indications with a larger number of cases, such as neuro and spine surgery. We also rely on the use of artificial intelligence to analyse tissue and identify tumorous tissue in real time to be able to remove it with our CARLO.”
“Let’s go West, CARLO”, says Dr. Bernhard Schirmers, biggest institutional investor of AOT and founding partner of SHS Gesellschaft für Beteiligungsmanagement, indicating the company’s efforts to obtain FDA approval for its technology in the US market.
For CE certification, CARLO was used for the first time in a clinical study in the context of operations for jaw correction, which has proven the efficiency and safety of the technology in a clinical environment.
The University Hospital Basel, the Medical University of Vienna (AKH Wien) and the University Medical Centre Hamburg-Eppendorf took part in the study.