New surgical robotic platforms in China and their applications in urologic surgeries

1. Introduction

Due to the continuous progress in surgical methodologies and the swift evolution of surgical tools, minimally invasive procedures have emerged as the dominant approach in urologic oncology surgeries. Notably, robot-assisted surgery (RAS) has led to its extensive adoption in the surgical management of urinary system tumors due to its enhanced maneuverability, precision in suturing, and anastomotic capabilities. Since the first robot-assisted radical prostatectomy (RARP) was performed in China, over 580 000 cases of RAS have been conducted in the country by December 2024 (unpublished data). Among these, urological surgeries account for 48% of the total. By December 2024, over 400 robotic surgical platforms developed by various companies have been installed nationwide, with the da Vinci surgical system (da Vinci; Intuitive Surgical, Sunnyvale, CA, USA) accounting for over 90% (unpublished data). Nearly half of these robotic surgical platforms are installed in more economically developed and densely populated coastal cities and provinces such as Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, and Shandong. However, a fact that still deserves our attention is that the popularization of robotic surgical platforms has not yet met our demands. Taking Shanghai as an example, it is a metropolis with a population of 30 million residents and boasts over 35 robotic surgical platforms, ranking third in China in terms of the number of such platforms. The patients from Shanghai have comprehensive medical insurance policies that could cover a high percentage of the treatment expenses. However, the penetration rate of RAS is not as high as expected: the proportion of RARP among radical prostatectomy (RP) is approximately 65%; the robot-assisted radical cystectomy among radical cystectomy accounts for 49%, and robot-assisted partial nephrectomy (RAPN) and robot-assisted radical nephrectomy make up about 30% among kidney tumor surgeries (unpublished data). It is conceivable that in provinces with fewer robotic surgical platforms, the demand for robotic surgical platforms far exceeds their availability. We also need to note that, in addition to cancer treatments, various urological reconstructions and plastic surgeries have also significantly benefited from the RAS [1]. The inadequacy of surgical platforms may pose certain obstacles to the conduct of these types of surgery. Additionally, the cost of the da Vinci indirectly results in fewer robotic surgical platforms in many provinces. Thus, it is evident that, in China, RAS faces challenges such as high demand, inadequate installations, and high costs. It has to be noted that the da Vinci is also making changes to reduce the cost to better align with China's domestic needs. Reports showed that the fourth-generation of the da Vinci obtained registration approval from the National Medical Products Administration for domestically produced medical devices in June 2023 [2]. In December 2023, the first domestically produced da Vinci Xi surgical system was officially installed at Gansu Hospital Affiliated to Sun Yat-sen University Cancer Center [2]. Naturally, domestic companies from China are also accelerating the development of their own robotic surgical platforms [3]. In the last few years, new robotic platforms other than the da Vinci for laparoscopic surgery have been developed. It is believed that the latest generation of domestic robotic surgical platforms, equipped with a variety of new technologies and features, has the potential to increase the availability of RAS and lower the overall costs. Here, we will review these new robotic surgical platforms and their applications in urologic surgeries in China.

2. Multi-port robotic surgical systems

A multi-port robotic surgical system is an advanced platform that is usually featured with a patient cart, a surgeon console, and an image system. It usually has several robotic arms that are connected to the patient cart, eliminating the need for attachment to the operating table. The surgical instruments mimic human wrist movements, enabling surgical maneuvers at various angles. Some of the systems include a three-dimensional (3D) endoscope that captures surgical field images, which are projected onto synchronized screens in the surgeon console, creating a 3D visualization without goggles. Some of the systems achieve a 3D visual effect through the use of 3D glasses and a dedicated screen. The robotic arms are typically three arms, four arms, or modulated numbers of arms. Here, we attempt to classify the multi-port machines into two categories: those with an integrated design, similar to the da Vinci, and those with a modular design, similar to systems such as Senhance® [4] or HUGO [5,6].

2.1. Integrated systems

2.1.1. EDGE Medical MP1000 multi-port robotic surgical system (EDGE MP1000)

Since the first clinical trial in 2021, the EDGE MP1000 developed by Shenzhen Edge Medical Company (Shenzhen, China) has successfully completed over 4000 cases of surgery by December 2024 (unpublished data), comprehensively covering highly complex procedures across various departments including urology, gynecology, and thoracic surgery. These procedures for urology encompass challenging operations such as radical cystectomy, partial nephrectomy (PN), and RP.

Niu et al. [7] presented the outcomes of their randomized controlled trial, which compared the EDGE MP1000 with the da Vinci in RP. The findings revealed no statistically significant differences between the two groups regarding the median setup time (20 min vs. 21 min; p=0.4) or median blood loss (50 mL vs. 100 mL; p=0.7). The mean duration (standard deviation [SD]) of the surgeries was comparable (174.76 [SD 55.28] min vs. 155.67 [SD 35.37] min; p=0.19). Neither cohort encountered any intraoperative injuries to organs or blood vessels, and no safety-related adverse events were documented. Additionally, there were no postoperative complications in the immediate recovery period, and none of the patients reported incontinence during the 3-month follow-up period.

Gao et al. [8] have published the findings of their randomized controlled clinical trial, which compared the performance of the EDGE MP1000 and the da Vinci in RAPN. A total of 62 patients scheduled for RAPN were randomly allocated to either the da Vinci Si surgical system group or the EDGE MP1000 group. The results showed no statistically significant differences between the two groups in terms of median setup time (19.50 min vs. 22.00 min; p=0.068), operation duration (124.50 min vs. 100.00 min; p=0.059), warm ischemia time (WIT; 18.00 min vs. 16.00 min; p=0.068), or complication rates, positive surgical margin rates, or estimated glomerular filtration rates at the 3-month follow-up. Additionally, there were no significant differences in the National Aeronautics and Space Administration Task Load Index median scores assessing mental workload, physical demand, temporal demand, as well as overall performance, effort, or frustration levels between the groups.

2.1.2. Toumai® endoscopic surgical robot

The Toumai® endoscopic surgical robot, developed by Shanghai MicroPort MedBot (Group) Co., Ltd. (Shanghai, China), is one of the earliest robotic surgical platforms that have received medical device registration approval. In the study by Pokhrel et al. [9], the median operative times were as follows: 120 min for PN, 140 min for radical nephrectomy, and 210 min for RP. One PN case was performed off-clamp, while the WIT for the other two PN cases was 18 min. Additionally, the median docking times were 22 min for nephrectomy procedures and 20 min for RP, with no significant complications reported.

2.1.3. KD-SR robotic surgical system (KD-SR)

Shen et al. [10] and Li et al. [11] published two randomized controlled clinical studies comparing the KD-SR (Suzhou KangDuo Robot Co., Ltd., Suzhou, China) with the da Vinci, observing the safety and efficacy of RARP and RAPN, respectively. In the article about RARP, the authors noted that there was no significant difference in the incidence of urinary incontinence 1 month after surgery between the KD-SR group and the da Vinci group, nor were there any notable differences in terms of complications. However, the operative time was significantly shorter in the da Vinci group compared with the KD-SR group. Additionally, the console time in the KD-SR group was marginally longer than that in the da Vinci group. In the article about RAPN, the WIT was comparable between the KD-SR group and da Vinci group. There were no statistically significant differences in the postoperative estimated glomerular filtration rate. No disparities were observed in the incidence of intraoperative complications.

The same team conducted another study on more types of urological surgeries, including PN (n=28), urinary tract reconstruction (n=41)—pyeloplasty (n=26), ureteral reconstruction (n=3), and ureterovesical reimplantation (n=12), and RP (n=41) [12]. In the article, the authors indicated that the surgical success rates of pyeloplasty and ureterovesical reimplantation were 96% (25/26) and 92% (11/12) at the median follow-up of 29.5 months and 11.5 months, respectively.

2.1.4. Sentire Siteng® laparoscopic surgical robot (Sentire)

The Sentire, independently developed by Cornerstone Robotics (Shenzhen, China), has successfully completed all scheduled clinical validation surgeries in the Chinese mainland. The surgeries covered representative urological procedures such as RP, PN, and pyeloplasty. Currently, the Sentire has obtained medical device registration approval in China. However, published data related to the clinical trials are not yet available. According to the clinicalTrials.gov website, multiple multidisciplinary clinical trials for the Sentire are still ongoing, such as NCT06598085 and NCT06587152.

2.1.5. Micro Hand S surgical robotic system

In 2023, Li et al. [13] successfully performed dozens of remote RAPN utilizing the Micro Hand S surgical robotic system developed by Shandong Weigao Medical Robotics (Weihai, China). The primary conclusion of the article is as follows: “The findings reveal that the integration of 5G technology with robotic surgical platforms represents an innovative and promising telemedicine-based treatment option for renal tumors”. The article presents several surgical data points, including that 87% of the patients were at the clinical T1 stage, with a median surgical duration of 67 min. During the 5G-enabled telesurgeries, the median total delay was 167 ms. All procedures were successfully completed without the need for conversion to alternative surgical methods, and there were no major intraoperative or postoperative complications. Other literature pertaining to the Micro Hand S surgical robotic system mainly originates from general surgical procedures, wherein the authors present data on the robotic surgical platform's safety, stability, and efficacy [[14], [15], [16]].

2.2. Modular systems

The biggest difference between integrated systems and modular systems is that the latter have independent arm carts, with one arm on one patient cart. It is believed that independent patient carts of such modular systems could facilitate a broader range of surgical configurations for diverse procedures and offer the flexibility to adjust the working angle without altering the port configuration, which is particularly advantageous in multi-quadrant surgeries [5]. However, due to the differences in the setup process between modular systems and integrated systems which we are most accustomed to, a training program that familiarizes users with the device functionalities and docking angles is crucial for understanding the system's capabilities.

2.2.1. Carina™ robotic surgical platform

The Carina™ robotic surgical platform, developed by Ronovo Surgical (Shanghai, China), is currently the only modular system in China. It has completed clinical trials in urology, general surgery, gynecology, and thoracic surgery. However, its clinical trial data have not been fully disclosed yet. At the Society of Robotic Surgery Annual Meeting, Dr. Ye's team presented their findings using the Carina™ robotic surgical platform to perform RARP (n=11) and RAPN (n=7) [17]. All operations were successfully completed without any surgical modifications or the addition of unplanned ports, and no intraoperative technical faults were recorded. For RARP, the mean system preparation time was 9.6 (SD 2.7) min, console time 106.8 (SD 21.1) min, and estimated blood loss 65.6 (SD 41.2) mL. For RAPN, the mean system preparation time was 14.2 (SD 1.7) min, console time 62.6 (SD 25.0) min, and estimated blood loss 47.2 (SD 7.6) mL.

3. Single-port (SP) robotic surgical systems

The da Vinci SP surgical system (da Vinci SP; Intuitive Surgical, Sunnyvale, CA, USA), a well-known representative of SP robotic systems, emerged from surgeons' desire to minimize patient trauma. It mimics a multiport robotic surgical platform by inserting double-jointed instruments through a single multichannel port, enabling surgical triangulation similar to multiport procedures. Its key challenge lies in all robotic arms entering through one port and triangulating within the cavity, posing issues with working distance, articulation, and instrument strength. In China, the publicly disclosed SP robotic systems mainly include the SHURUI SP robotic surgical system (SHURUI; Beijing Surgerii Technology Co., Ltd. Beijing, China) and the EDGE SP1000 SP robotic surgical system (EDGE SP1000; Shenzhen Edge Medical Company, Shenzhen, China).

3.1. SHURUI

The SHURUI has been meticulously crafted utilizing a dual-continuum mechanism alongside the innovative core nitinol arm technology, specifically designed to address a shortcoming of the da Vinci SP: the susceptibility of its wire-driven mechanism in the da Vinci SP to mechanical deformation, which consequently impairs force transmission and diminishes workspace volume. Peng et al. [18] were the first to report their experience with the SHURUI for PN. Their study involved 13 patients, consisting of seven males and six females. The tumors had a mean diameter of 1.9 (SD 0.9) cm. The study found that the mean WIT was 26.2 (SD 9.7) min, device docking time 3.6 (SD 1.8) min, and robotic arm operation time 124.7 (SD 40.4) min. Later, the same research team published their findings on the use of the SHURUI for RARP [19]. They reported a median operative time of 229 min (ranging from 194 min to 317 min) and a median console time of 167 min (ranging from 141 min to 265 min). One month after surgery, the continence rate was 73% (eight out of 11 patients).

In 2023, another team, led by Wang et al. [20], conducted 16 cases of RARP using the SHURUI. Their study revealed a mean operative time of 226.3 (SD 52.0) min and a mean console time of 183.4 (SD 48.3) min. The mean estimated blood loss was 116.3 (SD 90.0) mL. At the 30-day postoperative follow-up, 12 out of 16 patients reported using no more than one urinary pad per day. Furthermore, all patients reported satisfactory urinary control and no need for pads 6 months after surgery.

In another retrospective comparative study between the SHURUI and the da Vinci SP, the authors indicated that the operative time was relatively longer in the SHURUI group; however, the positive surgical margin rate, extracapsular extension rate, and urinary incontinence recovery were comparable between the two groups [21].

3.2. EDGE SP1000

EDGE SP1000 is the first SP robotic surgical platform in China to enter registered clinical trials, with over hundreds of cases of clinical application in China and has obtained national registration certification. Although the clinical trial data for urological surgery have not yet been disclosed, there are some studies that provide us with a preliminary understanding of its clinical performance. In its preclinical studies, the effectiveness of the EDGE SP1000 in performing porcine nephrectomy was investigated. The researchers reported that the mean time to establish the operation channel was 12.4 (SD 1.52) min, to install the EDGE SP1000 was 2.8 (SD 0.84) min, and to dissociate and remove the kidney was 47 (SD 5.61) min [22]. Chen et al. [23] shared their clinical experience utilizing the EDGE SP1000 in gynecological surgeries, noting an mean docking duration of 21.3 (SD 3.4) min. For benign conditions, the mean overall operative time was 190.1 (SD 83.3) min, whereas for malignant cases, it was 254.4 (SD 59.4) min. In no instance was an extra assistant port needed, nor was there a requirement to convert to conventional laparoscopy or laparotomy. Currently, multiple clinical trials are ongoing for EDGE SP1000, and we eagerly anticipate their results.

4. 5G telesurgery

Due to the advancement of 5G technology, the majority of robotic surgical systems discussed above have successfully executed telesurgery. As indicated before, the latency for surgeries performed via 5G is remarkably low, thereby instilling significant confidence in the feasibility of telesurgery [13]. In November 2023, Moschovas et al. [24] performed a tele-RP on a 71-year-old male patient using the EDGE MP1000. There were no delays or issues with the network connection between the centers. The procedure was completed in 60 min, with no complications during or after the surgery. However, the authors also emphasized that we must remain mindful of the fact that the availability of infrastructure for 5G internet equipment is essential for the feasibility of such surgeries. Dr. Zhang's team conducted telesurgery between two hospitals located in Beijing and Sanya, with a round-trip communication distance exceeding 6000 km [25]. Six cases of urological telesurgery, involving four different urological organs and five different types of operations, were successfully performed, demonstrating the safety, reliability, and utility of telesurgery. Naturally, the authors also mentioned that telesurgery necessitates the installation of complete robotic systems at both locations to ensure safety. Additionally, preoperative planning is crucial, as the primary surgeon and the assistant team are in different locations, making coordination and collaboration between the two teams vital.

5. Future prospects—challenges and improvements

In China, a plethora of domestically-developed robotic surgical systems have been successfully integrated into clinical practice, facilitating a diverse array of surgical procedures. Nevertheless, there remain several key areas warranting further attention.

Foremost among these is the performance of the robotic surgical systems. Existing literature underscores the da Vinci's notable advantages in terms of the overall surgical duration and preoperative preparation time. Admittedly, it may seem unfair to compare these new machines, which have only been developed for a few years, to the da Vinci, which boasts a history of over 20 years. As surgical data continue to accrue, clinicians will impart invaluable feedback to engineers, driving a natural selection process where only the most efficacious machines will attain widespread utilization. This process, of course, requires more time, more cases, more data, and more fine-tuning of software and hardware. In addition, stability of the robotic systems emerges as a pivotal factor, and it is an even more critical issue from a safety perspective. Continued observation and refinement in this domain are imperative.

The nascent development of SP robotic surgical platforms in China harbors immense potential for expansion. Previously, multi-arm robotic surgical platforms were employed in attempts to achieve an SP approach, yet this endeavor encountered significant technical hurdles, including arm interference and restricted mobility. The advent of SP robotic surgical platforms promises to mitigate these challenges. We have already witnessed the benefits of SP technology, including more precise manipulation, reduced trauma, reduced preoperative preparation time, and a faster recovery. However, due to the higher mechanical complexity and technical requirements of SP robotic surgical platforms compared with multi-arm robotic surgical platforms, their operational performance has always been a concern. Specifically, SP robotic surgical platforms may exhibit weaker grasping force, arm strength, and operational precision than multi-arm robotic surgical platforms, as well as a longer learning curve.

The emergence of so many new domestic robotic surgical platforms has sparked intense competition, which is bound to impact robotic surgical platform pricing. We anticipate a drop in prices, as this would ease the burden on hospitals, healthcare providers, and patients. Indeed, we have already witnessed the domestically produced da Vinci leading to a nearly 20% price reduction in recent years, a trend that is likely to drive down the costs of other robotic surgical platforms as well. However, we also harbor some concerns about this price decrease. We hope that the high development costs and low selling prices of new robotic surgical platforms will not adversely affect their ongoing research or development, or compromise their manufacturing quality.

At last, the clinical deployment of telemedicine confronts multiple obstacles, including the widespread implementation of 5G internet, the synchronized installation of robotic platforms across medical institutions, the coordination and training of surgical teams at disparate locations, and, critically, ethical contemplations and regulatory scrutiny. We can see that many platforms have already achieved 5G remote surgery, but more validation is needed before this technology can be widely applied in clinical practice.

The ascending trajectory of domestically-produced robotic surgical platforms in China is progressively challenging the da Vinci's supremacy. It is our hope that this competitive dynamic will catalyze further technological advancements and contribute to a reduction in overall expenses.

Author contributions

Study concept and design: Dingwei Ye.

Data acquisition: Hongkai Wang.

Data analysis: Dingwei Ye, Hongkai Wang.

Drafting of manuscript: Hongkai Wang.

Critical revision of the manuscript: Dingwei Ye.

Conflicts of interest

The authors declare no conflict of interest.