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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Initial results for supraglottic carcinoma resection using the Medrobotics Flex system are encouraging with excellent local tumor control.

Transoral robotic excision of laryngeal papillomas with Flex® Robotic System - A novel surgical approach.

INTRODUCTION: Recurrent respiratory papillomatosis results in hoarseness, stridor and airway obstruction. Management is surgical, with most surgeons using microdebrider or laser. Transoral robotic surgery (TORS) has been successfully utilised for the excision of oropharyngeal malignancies and paediatric airway surgery. This is the first case report of TORS being used for the excision of laryngeal papillomas. CASE REPORT: A 36 year old Chinese female was diagnosed with juvenile onset recurrent respiratory papillomatosis. She had 4 previous laryngeal surgeries. She was pregnant in her 2nd trimester and experienced rapid progression of her disease, leading to impending airway compromise. At her latest surgery (2 years ago), poor laryngeal exposure was encountered during laryngoscopy which made the surgery technically challenging. Thus, a flexible robotic system (Flex® Robotic System, Medrobotics Corporation, Raynham, Massachusetts, USA) was utilised with the aim of providing better surgical exposure. During surgery, laryngeal intubation was not possible and her airway was secured with needle cricothyroidotomy followed by tracheotomy. Transoral robotic excision of laryngeal papillomas was performed successfully. Complete excision of obstructing papillomas was achieved with postoperative restoration of airway and voice. DISCUSSION: Utilisation of TORS improved visualisation, dexterity and access. Drawbacks include cost, set up time, requirement for special equipment and advanced training. TORS approach can be considered as an alternative to the usual laryngoscopic technique, especially in cases where difficult anatomy and poor laryngeal exposure is anticipated.

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

OBJECTIVES: The 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. METHODS: This 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. RESULTS: Tissue 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. CONCLUSIONS: In 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.

Minimally invasive transoral robotic surgery for hiloparenchymal submandibular stone: Technical note on Flex Robotic System.

Flex Robotic System allows a minimally invasive approach for transoral removal of submandibular salivary stones.

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.

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

BACKGROUND: This multicenter, retrospective review documents the initial experience using the Flex system for transoral surgery in 2 United States academic centers. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Evolution of robotic systems for transoral head and neck surgery.

Oropharyngeal tumor is traditionally resected from an open approach, often necessitating the need of a midline mandibulotomy in order to remove tumor safely with oncologic margins. The limitations imposed by a transoral route include poor visualization of the inferior extent of the oropharynx, rigid instrumentation, and inability to resect tumor that extends caudally into the supraglottis. While visualization with angled endoscopes, coupled with flexible laser development and microscopic magnification may overcome some of these limitations, this technique suffers from linear trajectory of the instruments which hampers expedient surgical resection in a 3-dimensional fashion. With development of the Da Vinci Surgical System, the safety and oncologic feasibility of removing oropharyngeal tumors are made possible because it provides a 3-dimensional magnification of the surgical field and wristed maneuverability of the surgical instruments which enable surgeons to operate around tight anatomical confines. Nevertheless, this first-generation robot is continually being modified with more flexibility and maneuverability through the development of robots like the FLEX Robotic System and more recently the Da Vinci Single Port System (SP). In this review, we will discuss the historic developments of robots for transoral applications, present the current approved robotic systems, and highlight the upcoming robots for transoral robotic surgery (TORS). Finally, we will also propose an ideal TORS surgical robot by highlighting the engineering technologies to accomplish these challenges.