Medrobotics Corporation
Flex
Chronology
Updated Feb 2025
Bankruptcy: liquidation. Jan 24, 2022.
First series (outcomes). 2016.
FDA clearance July 2015.
First clinical papers published (Europe). 2015
CE clearance March 2014
Preclinical studies. 2014.
The Medrobotics Flex (Medrobotics Corp., Raynham, Massachusetts, USA) obtained European CE clearance in March 2014 and later American FDA clearance in July 2015. This system was purposefully crafted for transoral surgical procedures.
At its core, the Flex can be described as a tele-manipulated flexible endoscope equipped with two lateral working channels. Surgeons introduce instruments through these channels and directly manipulate them at the head of the surgical table. While the fundamental instrument design resembles those used with conventional endoscopes, the Flex features a more intricate hand-set and wrist articulation. The system, comprising two carts, is conveniently portable.
The system’s developer claimed the merits of a flexible transoral approach as in contrast the da Vinci system was not originally intended for transoral use. Experienced surgeons understand that exposure is pivotal and if often influences the suitability of cases for TORS, particularly for distal targets like the larynx. The configuration of the da Vinci’s multiport device creates challenges in terms of surgical field exposure and instrument maneuverability and collisions, greater the greater the distance from the teeth. The situation is further complicated by the wider 8 mm endowrist of the dV Xi system, which are, anyway, unsuitable for glottic procedures.
A distinct advantage of the Flex was theoretically its cost-effectiveness, as associated costs were notably lower than that of the da Vinci system. However, the same strengths that distinguished the Flex also carried inherent weaknesses. While approved for various trans-orificial approaches such as trans-nasal and trans-vaginal procedures, the Flex lacks suitability for percutaneous approaches, precluding its use in laparoscopic procedures. Cost-efficiency is a fundamental consideration in robotic surgery programs, particularly those in multi-specialty medical centers. The economic viability of such programs significantly relies on case volume. Omitting laparoscopic procedures from the Flex’s scope eliminates a substantial portion of potential cases. Therefore, except in instances of larger medical centers equipped with multiple robotic systems, the Flex was not an optimal choice. Ultimately, the project couldn’t endure due to its economic infeasibility.
In December 2020 Endobotics, LLC won a patent and trade secrets infringement lawsuit against medrobotics corporation. Founded in 2016, Endobotics possessed hand-held articulating instrument technology, originally developed and marketed by Cambridge Endoscopic Devices, Inc. as a full line of disposable, hand-held laparoscopic devices with 7 degrees of freedom. Cambridge Endoscopic Devices had filed for bankruptcy in early September, 2015. Medrobotic Corporation was liquidated for bankruptcy on January 24, 2022.
Nonetheless, the Flex has unmistakably carved a path of progress, and with time, it is poised to secure a place in the annals of surgical technology as a pioneering solution.
Links:
- Medrobotics Corporation (LinkedIn)
- Overview animation (YouTube)
References:
Preclinical studies
Richmon JD. Transoral palate-sparing nasopharyngectomy with the Flex® System: preclinical study. Laryngoscope. 2015 Feb;125(2):318-22. doi: 10.1002/lary.24918. Epub 2014 Sep 12
Funk E, Goldenberg D, Goyal N. Demonstration of transoral robotic supraglottic laryngectomy and total laryngectomy in cadaveric specimens using the Medrobotics Flex System. Head Neck 2017 Jun;39(6):1218-1225. doi: 10.1002/hed.24746. Epub 2017 Mar 16
Friedrich DT, Scheithauer MO, Greve J, Duvvuri U, Sommer F, Hoffmann TK, Schuler PJ. Potential Advantages of a Single-Port, Operator-Controlled Flexible Endoscope System for Transoral Surgery of the Larynx. Ann Otol Rhinol Laryngol. 2015 Aug;124(8):655-62. doi: 10.1177/0003489415575548. Epub 2015 Mar 10.
Friedrich DT, Scheithauer MO, Greve J, Rotter N, Doescher J, Hoffmann TK, Schuler PJ. Application of a computer-assisted flexible endoscope system for transoral surgery of the hypopharynx and upper esophagus. Eur Arch Otorhinolaryngol. 2017 May;274(5):2287-2293. doi: 10.1007/s00405-017-4498-7. Epub 2017 Feb 24.
Lerner MZ, Tricoli M, Strome M. Abrasion and blunt tissue trauma study of a novel flexible robotic system in the porcine model. Am J Otolaryngol. 2017 Jul-Aug;38(4):447-451. doi: 10.1016/j.amjoto.2017.04.002. Epub 2017 Apr 11. PMID: 28413075
Cottrill EE, Funk EK, Goldenberg D, Goyal N. Transoral Thyroidectomy Using A Flexible Robotic System: A Preclinical Cadaver Feasibility Study. Laryngoscope. 2019 Jun;129(6):1482-1487. doi: 10.1002/lary.27543. Epub 2018 Oct 4
Zhu TS, Godse N, Clayburgh DR, Duvvuri U. Assessing the learning curve associated with a novel flexible robot in the pre-clinical and clinical setting. Surg Endosc. 2022 Feb;36(2):1563-1572. doi: 10.1007/s00464-021-08445-7. Epub 2021 Mar 22
First clinical applications
Schuler PJ, Duvvuri U, Friedrich DT, Rotter N, Scheithauer MO, Hoffmann TK. First use of a computer-assisted operator-controlled flexible endoscope for transoral surgery. Laryngoscope. 2015 Mar;125(3):645-8. doi: 10.1002/lary.24957. Epub 2014 Oct 7.
Remacle M, M N Prasad V, Lawson G, Plisson L, Bachy V, Van der Vorst S. Transoral robotic surgery (TORS) with the Medrobotics Flex™ System: first surgical application on humans. Eur Arch Otorhinolaryngol 2015 Jun;272(6):1451-5. doi: 10.1007/s00405-015-3532-x. Epub 2015 Feb 8
Remacle M, Prasad VMN. Preliminary experience in transoral laryngeal surgery with a flexible robotic system for benign lesions of the vocal folds. Eur Arch Otorhinolaryngol. 2018 Mar;275(3):761-765. doi: 10.1007/s00405-018-4900-0. Epub 2018 Feb 7
Persky MJ, Issa M, Bonfili JR, Goyal N, Goldenberg D, Duvvuri U. Transoral surgery using the Flex Robotic System: Initial experience in the United States. Head Neck. 2018 Nov;40(11):2482-2486. doi: 10.1002/hed.25375. Epub 2018 Oct 10.
Tan Wen Sheng B, Wong P, Teo Ee Hoon C. Transoral robotic excision of laryngeal papillomas with Flex® Robotic System – A novel surgical approach. Am J Otolaryngol. 2018 May-Jun;39(3):355-358. doi: 10.1016/j.amjoto.2018.03.011. Epub 2018 Mar 3
Other references
Mattheis S, Hasskamp P, Holtmann L, Schäfer C, Geisthoff U, Dominas N, Lang S. Flex Robotic System in transoral robotic surgery: The first 40 patients. Head Neck 2017 Mar;39(3):471-475. doi: 10.1002/hed.24611. Epub 2016 Oct 28
Sethi N, Gouzos M, Padhye V, Ooi EH, Foreman A, Krishnan S, Hodge JC. Transoral robotic surgery using the Medrobotic Flex® system: the Adelaide experience. J Robot Surg. 2020 Feb;14(1):109-113. doi: 10.1007/s11701-019-00941-2. Epub 2019 Mar 5
Krespi Y, Kizhner V, Koorn R, Giordano A. Anesthesia and ventilation options for flex robotic assisted laryngopharyngeal surgery. Am J Otolaryngol. 2019 Nov-Dec;40(6):102185. doi: 10.1016/j.amjoto.2019.02.016. Epub 2019 Feb 22
Hussain T, Lang S, Haßkamp P, Holtmann L, Höing B, Mattheis S. The Flex robotic system compared to transoral laser microsurgery for the resection of supraglottic carcinomas: first results and preliminary oncologic outcomes. Eur Arch Otorhinolaryngol. 2020 Mar;277(3):917-924. doi: 10.1007/s00405-019-05767-0. Epub 2020 Jan 1.
Barbara F, Cariti F, De Robertis V, Barbara M. Flexible transoral robotic surgery: the Italian experience. Acta Otorhinolaryngol Ital. 2021 Feb;41(1):24-30. doi: 10.14639/0392-100X-N0688
Capaccio P, Riva G, Cammarota R, Gaffuri M, Pecorari G. Minimally invasive transoral robotic surgery for hiloparenchymal submandibular stone: Technical note on Flex Robotic System. Clin Case Rep. 2022 Jan 24;10(1):e04529. doi: 10.1002/ccr3.4529.
J Granell
Robotic Surgeon
Prior to commencing my venture into robotic surgery, I had established a firm grounding as an oncologic surgeon. My experience encompassed a wide range of resective and reconstructive procedures, as well as proficiency in minimally invasive surgical techniques and endoscopic surgery. These acquired skills and expertise serve as fundamental pillars for achieving success within the realm of robotic surgery.