Clinical trials of the ALF-X system
The TELELAP ALF-X is now over 150 human surgeries as reported in Surgical Endoscopy, and achieving its commercial format.
"Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and malignant uterine early stage disease were prospectively included. We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches."
"It is a system of tele-surgical manipulation of the latest generation, designed and manufactured in Italy, the result of 12 years of advanced research promoted by the Italian pharmaceutical SOFAR SpA, the collaboration of the Joint Research Centre of the European Commission (JRC). TELELAP ALF-X It has a number of innovative features that make the minimally invasive endoscopic more easy and safe, improving the quality and effectiveness of surgery at low operating costs. Thanks to advanced ability to "kinesthetic sensibility," TELELAP ALF-X is the first system in the world It allows the surgeon to perceive the remote tissue consistency and the stresses exerted by the tools, allowing extreme delicacy of movement. These aspects are particularly important during dissections to save the neural structures and during reconstruction with stitches. The control station of TELELAP ALF-X is equipped with an advanced tracking system for ocular effectively control the endoscopic view, extolling the field of vision or moving in seconds in the center of the screen any area look: This feature avoids the involvement of an assistant and optimizes the reaction time to locate and centered in an area of interest. The ergonomics of the control station is designed to give comfort to the surgeon, reduce drastically his fatigue and thus enable him to maintain focus and concentration up to the terminal stages of the intervention, which are often also the most critical. The ease of use for the operating room staff was a key criterion of design TELELAP ALF-X. In fact, the system may include up to four manipulator arms removable apartments that can be prepared for use in seconds, adapting to any position of the patient and without affecting the duration of the intervention. After entering through the doors of access, surgical instruments move with great precision while keeping as a fulcrum point minimum resistance, thereby reducing the tearing of the mini-incision. The modularity and adaptability, coupled with the low cost of its equipment, make TELELAP ALF-X a multi-disciplinary in general surgery, gynecology, urology and thoracoscopy and economically advantageous in terms of productivity, thus usable in different interventions per day. "
Source: SOFAR, ALF-X publications