Clinical Publications

A selection of conference posters, videos, presentations and journal publications related to the use of FlexDex technology (first generation FlexDex Needle Driver and AXIUS Needle Driver)

Conference Posters & Presentations

Robotic-Like Suturing Without A Robotic Surgical System

Cost and Time Comparison with Robot

Comparison of 35 procedures using FlexDex and 3D vision with a similar case matched series of 101 robotic procedures from a larger hospital within the same health system

“In conclusion, this retrospective review using concurrent case controls demonstrate that ENDOEYE FLEX 3D and FlexDex can provide excellent alternative to the da Vinci system in suture intensive procedures. This can be accomplished at lower startup and lower maintenance costs both initially and year over year.

We demonstrate equivocal or better OR times both in utilization and in cut to close times in certain cases. We demonstrated a significant difference in Contribution Margin as compared to the da Vinci system. The combined technologies demonstrate time and financial savings compared to the da Vinci system in this single system assessment.

Overall, the ENDOEYE FLEX 3D and FlexDex eliminated the reliance on tacking devices and enabled “robotic-like” suturing for both mesh fixation and fascial closure.”

View poster here

Kent Bowden, Munson Healthcare Cadillac, Cadillac, MI SAGES, Seattle, WA, 2018

A Head-To-Head Comparison Of Increased Degrees-Of-Freedom (IDOF) Laparoscopic Instruments For Complex Angle Intracorporeal Suturing

Comparison with Hand-Held Articulating Instruments

"DV [da Vinci] still remains the best overall IDOF [increased degree of freedom] system for complex suturing tasks but is also by far the most expensive and has the largest footprint of all of the instruments we evaluated. Of the novel singular IDOF instruments we assessed, FD [FlexDex first generation needle driver] had the shortest learning curve, added the least overall work-load demand and augmented the capabilities of the experienced surgeons."

Colorado, 2022: Posters. Surgical Endoscopy 36 (Suppl 1), 70–218, P338 (2022). https://doi.org/10.1007/s00464-022-09220-y

Danny Sherwinter et al, Maimonides Medical Center, Brooklyn, NY SAGES, Denver, CO, 2022

Laparoscopic Suturing During Radical Prostatectomy with FlexDex System: First Case in Europe

First Prostatectomy in Europe

"The learning curve for laparoscopy is steeper than for robotic surgery and instruments like the FlexDex may help to bridge this difference. The instrument may provide an alternative to the surgeon that is both more intuitive to use than traditional laparoscopy and more cost effective than robotic surgery."

European Urology Supplements 17 (7), Pe2381 (2018). https://doi.org/10.1016/S1569-9056(18)32753-2

Antonio Amodeo et al, Istituto Oncologico Veneto, Italy ERUS, Marseille, France, 2018

Journal Publications

Safety and Efficiency of an Articulating Needle Driver in Advanced Laparoscopic Abdominal Surgery

Walderik van der Vliet et al, Máxima Medical Center and Maastricht University, The Netherlands

This study included 45 procedures using the FlexDex Needle Driver over a period of 16 months, including laparoscopic Roux-en-Y gastric bypass, right-sided hemicolectomy and diaphragmatic hernia repair with Nissen fundoplication.

“The initial learning curve for this instrument comprised 11 cases, reaching the optimization phase.... Within the confines of these early results, these outcomes may indeed reflect the full potential of a LAND [laparoscopic articulating needle driver] in advanced laparoscopic surgical procedures as a safe and effective tool to enhance dexterity and precision during laparoscopic suturing and knot tying.”

van der Vliet WJ, Spaans LN, Bonouvrie DS, Uittenbogaart M, Leclercq WKG. Safety and Efficiency of an Articulating Needle Driver in Advanced Laparoscopic Abdominal Surgery. J Laparoendosc Adv Surg Tech A. 2022 Apr;32(4):422-426. doi: 10.1089/lap.2021.0272. Epub 2021 Dec 21. PMID: 34936817: view here

Laparoscoic Supracervical Hysterectomy and Sacrocervicopexy Using Flexdex's Platform Technology with Extraction of The Surgical Specimen by the Posterior Colpotomy for the Treatment of Uterine Prolapse

Charles Souza et al, Instituto Crispi, Rio de Janeiro, Brazil

“All the suturing during the surgery was accomplished utilizing only one trocar arrangement, enabled by the virtual center of rotation of the FlexDex platform... the closure of the posterior vaginal wall was facilitated by the endless rotation of the platform, enabling the ideal movement of the needle, following its curvature.

The FlexDex platform allows similar amplitude and intuitive wrist movement of the surgeon during complex procedures such as the one here presented – being a cost-effective alternative to the robot technology in countries where it is not readily available.”

CA Souza, RT Pazello, F Hajar. 1201 Laparoscoic Supracervical Hysterectomy and Sacrocervicopexy Using Flexdex's Platform Technology with Extraction of The Surgical Specimen by the Posterior Colpotomy for the Treatment of Uterine Prolapse. Journal of Minimally Invasive Gynecology, Volume 26, Issue 7, Supplement, 2019, Page S214, ISSN 1553-4650: view here

A Novel Intuitively Controlled Articulating Instrument for Reoperative Foregut Surgery: A Case Report

Cory Criss et al, C. S. Mott Children’s Hospital, University of Michigan, Ann Arbor, MI

“We present a case of a Nissen fundoplication where previous adhesions impacted working space and visualization, prompting the use of the novel laparoscopic instrument to enhance suturing and knot tying. Overall, the instrument demonstrated effectiveness, with an improved ability to suture at the hiatus and distal esophagus.

By providing articulation and intuitive control, the needle driver successfully enables suturing and knot tying in limited spaces, ideal for minimally invasive foregut surgery.”

Criss C, Ralls M, Johnson K, Awtar S, Jarboe M, Geiger J. A Novel Intuitively Controlled Articulating Instrument for Reoperative Foregut Surgery: A Case Report. Journal Of Laparoendoscopic & Advanced Surgical Techniques, Volume 27, Number 9, 2017 DOI: 10.1089/lap.2017.0107: view here

Learning Curve in Two-Port Laparoscopic Gastropexy Using FlexDex

Federico Massari et al, Clinica Veterinaria Nervianese, Italy

This study included 16 veterinary procedures using the FlexDex Needle Driver in laparoscopic gastropexy in dogs.

“These results demonstrate that FlexDex has a clear benefit in technically challenging laparoscopic operations, such as those requiring intracorporeal suturing. The learning curve is steep, and in specialist hands, within the first 12 cases, the surgical time is reduced by 73%, representing a reduction in anaesthetic risks to the patient as well as more cost-efficient surgery.”

Massari F, Kelly GMM. Learning Curve in Two-Port Laparoscopic Gastropexy Using FlexDex. Animals (Basel). 2024 Jul 9;14(14):2016. doi: 10.3390/ani14142016. PMID: 39061478; PMCID: PMC11274303: view here

Use of a Novel Articulating Laparoscopic Needle Driver for Partial nephrectomy: An Initial Experience

Hari Vigneswaran et al, University of Illinois, Chicago, IL

“A total of 20 patients underwent PN [partial nephrectomy] with 10 patients assigned to each of the LPN [laparoscopic PN] and RALPN [robot assisted PN] cohorts. Patients who underwent LPN with a novel articulating needle driver demonstrated equivalent results to RALPN across several key outcomes.”

“This technology may offer a minimally invasive option for clinicians either in centers which do not have robotic technology or as an alternative to traditional laparoscopic techniques.”

Vigneswaran H, Dobbs R, Huang J, Sofer L, Halgrimson W, Crivellaro S. Use of a Novel Articulating Laparoscopic Needle Driver for Partial nephrectomy: An Initial Experience. Urology, Volume 132, 2019; 123-129: view here

Clinical Experience of Thoracoscopic Sleeve Lobectomy Using a Novel Needle Holder

Tatsuo Nakagawa et al, Tenri Hospital, Japan

“In conclusion, this novel, uniquely articulated Needle Driver is expected to improve thoracoscopic bronchoplasty... The instrument could provide surgeons with a pathway that is more intuitive than traditional surgery and more cost-effective than robotic surgery.”

Nakagawa, Tatsuo et al. Clinical Experience of Thoracoscopic Sleeve Lobectomy Using a Novel Needle Holder. Seminars in Thoracic and Cardiovascular Surgery, Volume 30, Issue 3, 381 - 383. doi: 10.1053/j.semtcvs.2018.07.001: view here

Bold fonts in all clinical publications have been added for emphasis.