Flex Robotic System Research Articles

The Flex Robotic System in Head and Neck Surgery: A Review.

The Flex Robotic System is a device intended for robot-assisted visualization and surgical site access to the head and neck. The aim of this review is to summarize the current knowledge about the Flex Robotic System in head and neck transoral robotic surgery (TORS). The primary search was performed using the term "Flex Robot" across several databases (PubMed, Embase, Cochrane, Scopus). Patients were treated for both benign and malignant diseases. The oropharynx was the most frequent site of disease, followed by the supraglottic larynx, hypopharynx, glottic larynx, oral cavity, and salivary glands. Most of the studies did not reveal major intra- or post-operative complications. Bleeding incidence was low (1.4-15.7%). Visualization of the lesion was 95-100%, while surgical success was 91-100%. In conclusion, lesions of the oropharynx, hypopharynx, or larynx can be successfully resected, thus making the Flex Robotic System a safe and effective tool, reducing the morbidity associated with traditional open surgery.

Robotic transanal excision of rectal lesions: expert perspective and literature review

Transanal excision of benign lesions, moderately or well-differentiated rectal T1 adenocarcinomas is typically completed via transanal endoscopic microsurgery (TEM) or laparoscopic transanal minimally invasive surgery (TAMIS). Robotic platforms provide ergonomic comfort in an enclosed space, enhanced range of motion, and superior 3D visualization. This study sought to perform a literature review of robotic TAMIS (R-TAMIS) and provide expert commentary on the technique. A Pubmed literature search was performed. Study design, robot type, indication, techniques compared, surgical margins, conversion, complications, operative time, estimated blood loss, patient positioning, and defect closure were collected from included articles. Expert opinion on pre-operative planning, technical details, and possible pitfalls was provided, with an accompanying video. Twelve articles published between 2013 and 2022 were included. Five were case reports, three case series, two prospective cohort studies, one retrospective cohort study, and one Phase II trial. The Da Vinci Si (n = 3), Xi (n = 2), single port (n = 3) and flex robotic system (n = 2) were used. Five studies reported negative surgical margins, one reported positive margins, and six did not comment. Operating room time ranged from 45 to 552 min and EBL ranged from 0 to 100 mL. Patient positioning varied based on lesion location but included supine, prone, modified lithotomy, and prone jackknife positions. 11/12 studies reported defect closure, most commonly with V-Loc absorbable suture. We recommend pre-operative MRI abdomen/pelvis, digital rectal exam, and rigid proctoscopy; prone jackknife patient positioning to avoid collisions with robotic arms; and defect closure of full-thickness excisions with backhanded running V-Loc suture.

Robotic endoscopic submucosal dissection and full-thickness excision for laterally spreading tumors of the rectum

Endoscopic submucosal dissection (ESD) is technically demanding and time-consuming. Moreover, it bears a high risk of adverse events compared to other endoscopic methods, due to the lack of tissue manipulation. Robotic technology can significantly reduce the time of the procedure and increase the rate of complete resection for ESD. In the case of an unclear deep margin it allows to proceed to the full-thickness excision of the bowel wall. While the gain over transanal endoscopic microsurgery (TEM) is limited today, the longer systems currently under development will allow these complex procedures to be performed at least in the left side of the colon. The Supplementary video shows the application of the Flex Robotic System to perform an ESD and a full-thickness excision.

Transorale Resektion von supraglottischen Larynxkarzinomen mit dem Flex Robotic System

The Flex Robotic System (Medrobotics, Raynham, MA, USA) allows flexible transoral endoscopic resection of head and neck tumors. The current article presents functional and first oncologic experiences with flexible transoral robot-assisted surgery for resection of supraglottic laryngeal tumors. From July 2014 to February 2020, supraglottic cancers in 32patients (T1 = 11, T2 = 20, T3 = 1) were resected using the Flex Robotic System in the authors' clinic. Within aprospective clinical study, the feasibility, complications, and oncologic results were assessed. Tumors could be exposed, visualized, and successfully resected in all patients. In difficult-to-reach anatomic regions such as the aryepiglottic fold or petiole, the system provided avery good surgical overview. No serious adverse events occurred. Overall survival and local tumor control after 2years were 88 and 94%, respectively. In conclusion, supraglottic tumors in difficult-to-reach areas have been successfully resected using the Flex Robotic System, with excellent local tumor control.

The Flex robotic system compared to transoral laser microsurgery for the resection of supraglottic carcinomas: first results and preliminary oncologic outcomes.

Transoral robotic surgery (TORS) has the potential to improve some inherent disadvantages of transoral laser microsurgery (TLM). Here, we retrospectively assessed the application of the Medrobotics Flex system for the resection of supraglottic carcinomas compared to TLM. 84 patients underwent surgery for supraglottic carcinomas with the Flex robotic system (n = 19, T-stage distribution in %: T1 42, T2 47, T3 11, T4 0) or TLM (n = 65, T-stage distribution in %: T1 40, T2 44, T3 14, T4 2). Clinical and oncologic parameters were compared. All surgeries were successfully completed with the Flex system and tracheostomy rate was 13%. For patients with adequate follow-up, 24-month disease-free survival was 71.4% (n = 5/7) after TORS compared to 64.9% (n = 24/37) after TLM. Local recurrence rates were 0% for TORS and 11% for TLM. Initial results for supraglottic carcinoma resection using the Medrobotics Flex system are encouraging with excellent local tumor control.

Transoral surgery using the Flex Robotic System: Initial experience in the United States.

This multicenter, retrospective review documents the initial experience using the Flex system for transoral surgery in 2 United States academic centers. All patients who underwent transoral robotic surgery using the Medrobotics Flex Robotic System (Raynham, MA) between September 2015 and May 2017 were reviewed. Rates of successful surgery and complications were evaluated. Thirty-six men and 32 women were enrolled in the study. The average age was 55.6 years (range 17-82 years). The Flex system was used successfully in surgery of the tongue base, the palatine tonsils, the supraglottis, the glottis, the hypopharynx, the oral tongue, and the soft palate. Only 6 cases (7.6%) required readmission after discharge. There were no intraoperative or immediate postoperative complications, with no cases of intraoperative hemorrhage. To the best of our knowledge, this is the first study in the United States evaluating the use of the Flex system to safely resect lesions in the oral cavity, larynx, and pharynx.

Abrasion and blunt tissue trauma study of a novel flexible robotic system in the porcine model

ObjectivesThe objective of this study was to determine if a flexible robotic system caused increased tissue reaction when accessing the oropharynx and hypopharynx compared to intubation controls in only 2 scenarios: high speed tissue impact and multiple unit insertions and retractions. The data obtained were submitted as part of the entirety of information submitted for FDA approval. MethodsThis study consisted of 5 groups of Yorkshire pigs (2 animals per group). On Day 0, all animals were intubated. For group 1 (control), a second endotracheal tube was advanced to just above the vocal cords. In abrasion groups 2 and 3, the flexible robotic system was advanced against the oropharyngeal and hypopharyngeal tissues, respectively. In blunt trauma groups 4 and 5, the flexible robotic system was advanced at maximum speed (22mm/s) to collide with oropharyngeal and hypopharyngeal tissues, respectively. Pre- and post-procedure endoscopic assessments of tissue reaction were performed daily for 4 days. An independent reviewer graded tissue reaction using a 0–3 point scale. ResultsTissue reaction scores at each observation time point for all test groups were less than or equal to control scores except for one instance of moderate scoring (2 out of 3) on Day 2 for an animal in the blunt trauma group where reaction was likely intubation-related rather than device impact related. Otherwise, all flexible robotic system-treated animal scores were less than 1 by Day 4. ConclusionsIn this limited study, the flexrobotic system afforded surgical access to the oropharynx and hypopharynx without an increased level of abrasion or tissue trauma when compared to intubation alone.

Demonstration of transoral robotic supraglottic laryngectomy and total laryngectomy in cadaveric specimens using the Medrobotics Flex System.

Current management of laryngeal malignancies is associated with significant morbidity. Application of minimally invasive transoral techniques may reduce the morbidity associated with traditional procedures. The purpose of this study was to present our investigation of the utility of a novel flexible robotic system for transoral supraglottic laryngectomy and total laryngectomy. Transoral total laryngectomy and transoral supraglottic laryngectomy were performed in cadaveric specimens using the Flex Robotic System (Medrobotics, Raynham, MA). All procedures were completed successfully in the cadaveric models. The articulated endoscope allowed for access to the desired surgical site. Flexible instruments enabled an atraumatic approach and allowed for precise surgical technique. Access to deep anatomic structures remains problematic using current minimally invasive robotic approaches. Improvements in visualization and access to the laryngopharyngeal complex offered by this system may improve surgical applications to the larynx. This study demonstrates the technical feasibility using the Flex Robotic System for transoral robotic supraglottic laryngectomy and total laryngectomy. © 2017 Wiley Periodicals, Inc. Head Neck 39: 1218-1225, 2017.

Flex Robotic System in transoral robotic surgery: The first 40 patients.

The Flex Robotic System is a new robotic device specifically developed for transoral robotic surgery (TORS). We performed a prospective clinical study, assessing the safety and efficacy of the Medrobotics Flex Robotic System. A total of 40 patients required a surgical procedure for benign lesions (n = 30) or T1 and T2 carcinomas (n = 10). Access and visualization of different anatomic subsites were individually graded by the surgeon. Setup times, access and visualization times, surgical results, as well as adverse events were documented intraoperatively. The lesions could be exposed and visualized properly in 38 patients (95%) who went on to have a surgical procedure performed with the Flex Robotic System, which were intraoperatively evaluated as successful. No serious adverse events occurred. Lesions in the oropharynx, hypopharynx, or supraglottic larynx could be successfully resected using the Flex Robotic System, thus making the system a safe and effective tool in transoral robotic surgery. © 2016 Wiley Periodicals, Inc. Head Neck 39: 471-475, 2017.

First use of a new retractor in transoral robotic surgery (TORS).

Transoral robotic surgery (TORS) has gained importance in head and neck surgery due to the possibility to visualize regions within the pharynx and larynx which are difficult to access. The success of transoral surgery depends on the exposure of the region of interest in order to allow visualization using a camera system. The Medrobotics Flex(®) Robotic System is a new flexible endoscopic system designed to overcome difficulties experienced in transoral surgery using other robotic systems with rigid endoscopes and instruments. In this article, we describe the first use of the Medrobotics Flex(®) Retractor in humans, a retractor designed for advanced transoral procedures. We report our experience in 11 patients requiring surgery of the oropharynx, hypopharynx, and supraglottic larynx. In all cases, we successfully exposed all targeted surgical regions. We experienced easy handling of the retractor alongside comparable positioning times and no observed mucosal damage.

Supporting evidence for robotic urological surgery

Since the introduction of the da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA, USA), the trend of minimally invasive surgery has accelerated. Recently, Intuitive Surgical launched the new da Vinci Xi platform and a prototype of a single-port surgical system. Other platforms from other robotic companies are on the horizon. The multiport surgical robotic ALF-X system (SORAR SpA, Milan, Italy) was initially introduced for gynecological surgery and was recently assessed in a preclinical animal study of robot-assisted partial nephrectomy (RPN) [1,2]. The ALF-X robot consists of a remote-controlled unit with a haptic handle, a three-dimensional high-definition monitor, an infrared eye-tracking system, and four detached robotic arms. The haptic feedback allows the surgeon to feel the force and resistance to the tissue. The surgeon can move the camera by gaze, and the system includes a large set of reusable instruments. Other manufacturers include Medrobotics (Raynham, MA, USA), which received U.S. Food and Drug Administration clearance for the Flex Robotic System in July 2015. The Flex Robotic System provides surgeons with single-site access visualization of hard-to-reach anatomical locations. Titan Medical (Toronto, ON, Canada) is a public company based on Single Port Orifice Robotic Technology. The system utilizes a 25-mm single-access port that contains two articulating instruments and a three-dimensional high-definition camera. The Korean domestic manufacturer Meree Company has developed the REVO I robot system. A clinical trial for the REVO I robot has been planned to supplement the global market. Meanwhile, the Korean national evidence-based health care collaborating agency (NECA) published a preliminary report on the clinical feasibility and cost-effectiveness of robot-assisted radical prostatectomy (RARP) from a total of five high-volume centers to provide fundamental data for instituting the national health policy. Concerning oncological outcomes, there were no significant differences in biochemical recurrence or the positive surgical margin rate. Concerning functional outcomes, RARP revealed the highest continence rate of 88.7% and 95.3% achievement of complete continence at postoperative 3 months and 3 years, respectively. Concerning cost analysis of the robotic system, with a threshold value of 30.5 million Korean won (KRW; 27,000 US dollars [USD]), a cost-effectiveness analysis of purchase among RARP, laparoscopic radical prostatectomy, and open radical prostatectomy (ORP) showed that RARP was not yet cost-effective. RARP could be cost-effective if the expenses could be reduced by 8.3 million KRW (7,400 USD). The effectiveness of the system could not offset the costs, because there was no significant difference in effectiveness among the different procedures, and the robotic cost of RARP was significantly more than that of the other procedures. However, owing to the short term of 1 year of data used for the cost-effectiveness analysis, long-term prospective study is necessary for further high-quality analysis. Recently, high-quality evidence is emerging comparing robotics with its traditional counterparts. In a study of RARP, Wallerstedt et al. [3] performed a prospective comparative trial of ORP versus RARP in a Swedish group of 14 centers including a total of 2,506 patients. The study was conducted prospectively over a 3-year period with patient-reported outcome measurement. The RARP group had less perioperative bleeding and shorter hospital stays. Reoperation during the hospital stay and seeking health care for cardiovascular reasons were more frequent after ORP. Haglind et al. [4] performed a prospective, controlled, nonrandomized trial evaluating urinary incontinence and erectile dysfunction in a total of 14 centers in Sweden including 2,625 patients and concluded that RARP was beneficial in preserving erectile function compared with ORP, with no statistically significant differences in continence or surgical margins. In an analysis of RPN, Choi et al. [5] performed a systematic review and meta-analysis of 23 studies and 2,240 patients. The authors concluded that RPN is more favorable than laparoscopic partial nephrectomy (LPN) in terms of a lower conversion rate to radical nephrectomy, more favorable renal function, a shorter length of hospital stay, and a shorter warm ischemia time. Potretzke and Bhayani [6] wrote an editorial comment on our previous article [5]. The authors mentioned the superior outcomes of RPN and the efficiency of excision and suturing. The true value of RPN is in its feasibility, accessibility, and learning curves, and the procedure competing with RPN now is not LPN, but rather radical nephrectomy, ablation, and observation. There will be more new robotic platforms, and new prospective randomized data will become available. The Korean Journal of Urology hopes to continue to share this knowledge on recent updates in robotic minimally invasive surgery and to enhance future perspectives on robotic minimally invasive surgery.