Figure 1: Market segments in robotic assisted surgery showing approximate order of maturity.
Many emerging areas of RAS are benefitting from innovation and gaining early adoption. Here we reflect on the current status of seven emerging segments where RAS offers great potential for treatment advantages:
1. Endoluminal robotics’ expansion into gastrointestinal procedure
Endoscopic treatment of colorectal cancer requires high skill levels in the diagnosis and resection of cancerous lesions. In lesion resection, clinicians can perform endoscopic submuscosal dissection. However, this is a long and technically demanding procedure, and a single electrosurgery tool must be manipulated through the working channel of the gastroscope to resect the lesion.
Endoluminal RAS systems are set to address this challenge with robotic endoscopic instruments that are independently controlled and provide the necessary countertraction. Clinical feasibility has been demonstrated by several systems, including those from EndoMaster and ColubrisMx (now Endoquest). The development of the miniature robotic instruments is far from easy, but several systems are in commercial development and set to expand the new segment of lower GI endoluminal robotics.
Figure 2: Colonoscopy procedure
2. Endovascular robotics’ transition to neurovascular
Ten years ago, commercial endovascular robotic systems had been developed by a range of companies including Corindus, Hansen, Sterotaxis, and Catheter Precision, targeting interventional cardiology procedures such as cardiac arrythmia treatment. A key benefit of these systems was reduced radiation exposure for physicians, because the procedure could be performed from a console away from the patient-side.
Whilst some companies are still pursuing these cardiac applications, others have turned their attention to neurovascular applications, for example Siemens Healthineers after its acquisition of Corindus.
It’s also around a decade since a series of positive clinical trials used mechanical thrombectomy to treat ischemic stroke. This is the most common form of stroke, where a clot blocks the supply of blood to the brain. Previously, only pharmacological intervention with intravenous delivery of ‘clot busting’ tPA had been proven effective.
Thrombectomy has since gained traction in the treatment of ischemic stroke, using aspiration-based reperfusion and stent retriever devices. This demands a skilled neurointerventionalist to navigate a tortuous path to the blocked vessel from entry in the groin. The painstaking process typically requires repeated rotation of guidewires with pre-shaped distal tips, which are hard to control, followed by deployment of the thrombectomy device to remove the clot.
Neurovascular robotic systems allow the distal tip of the guidewire to be actively controlled through several degrees of freedom, and they also eradicate operator exposure to x-rays. Around 700,000 ischemic strokes are suitable for mechanical thrombectomy in the US each year, but only a minority of patients receive this treatment. Endovascular robotics should make the procedure available for more patients. If it can also reduce the time to treat, then patient benefits will be significant. It’s often said that ‘time is brain’ in stroke, for example it is estimated that 1.9 million neurons are lost every minute before treatment. There are challenges in navigation and accurate robotic manipulation, but several promising systems are in commercial development.
Figure 3: Thrombectomy using a stent retriever device to remove the clot.
3. Remote telerobotics is getting closer
When surgical robotics was in its infancy in the 1980s, developments were fuelled by investment from Defense Advanced Research Projects Agency (DARPA) and National Aeronautics and Space Administration (NASA). These organisations were pursuing a vision of remotely operated surgery in military and space applications. Early commercial systems did adopt some principles of telesurgery, but the surgeon remained in the OR.
Today, a new age of remote RAS could be dawning. Earlier in 2024, Virtual Incision’s spaceMIRA robot was used in a simulated surgical procedure on the International Space Station, controlled by surgeons on Earth. Recent years have also seen a rise in long-distance clinical demonstrations of remote surgery, notably in China and India, revealing possibilities for remote care of patients in rural areas.
The Society of Robotic Surgery has been working to build consensus for telesurgery within the surgical community and wider stakeholders, hosting its inaugural telesurgery conference in 2024. There’s a clear need to provide care for patients located far from specialists who can treat their condition.
Technologically, the barriers hindering telesurgery 20 years ago, when the ‘Lindbergh operation’ was performed, have been removed by modern telecommunications networks. The bandwidth and low latency (<150ms) needed to perform surgery safely is now widely available. Remaining challenges are largely non-technical. Regulatory, legal, economic and organisational issues must be overcome to implement telerobotics within, or across, different healthcare systems or countries.
Figure 4: Remote telerobotics concept.
4. Robotic advancements in laparoscopy
Whilst many surgeons have switched to using soft tissue RAS, many have stayed with open surgery or conventional laparoscopy. However, some surgeons who prefer laparoscopic surgery are facing surgical team staffing challenges, so have learnt to perform laparoscopic surgery solo, whilst others would like to improve the efficiency of their assistants in the OR. Other surgeons are having to stay with laparoscopic surgery in new sites of care, like ASCs, where large, high functionality robotic systems are unsuitable.
Figure 5: Laparoscopic cholecystectomy.
New systems which address the needs of surgeons in conventional laparoscopy include Moon Surgical’s Maestro and Levita Magnetics’ MARS. They provide robotic control of the laparoscope and the tissue retractor, with the surgeon manipulating manual laparoscopy instruments. Others, such as Distalmotion’s Dexter, allow the surgeon to switch easily between laparoscopic instruments and a fully robotic procedure. This is enabled by the presence of a surgeon console within the sterile field.
These concepts are not entirely new of course, existing robotically controlled laparoscope holders including ProSurgics’s FreeHand and AKTORmed’s SOLOASSIST have been around for some time.
The new systems are set to establish an additional category of surgical robotics, and they are likely to be joined by others. For one thing, regulatory barriers to market entry are low – Moon Surgical gained FDA clearance under a Class I device classification. They are also designed to work with existing surgical instruments, so the system developer doesn’t need to develop its own electrosurgery tools or staplers. The challenges in this segment are largely commercial ones – identifying the most suitable procedures and geographies to target and growing the market in these segments.
5. RAS for transcatheter valve replacement
Treatment of heart valve disease via a transcatheter approach holds great promise, but the procedure is technically challenging. Many have tried and failed to build on the success of Transcatheter Aortic Valve Replacement (TAVR) by extending treatment to mitral and tricuspid valves.
Can RAS make a difference?
Heart valve treatment specialist Capstan Medical thinks it can. The company has described itself as ‘backing into’ robotics as a necessary solution. Meanwhile, Caranx Medical is also developing a robotic system to improve TAVR.
The patient population is estimated at 20M suffering from structural heart disease in US, Europe and Japan, the condition is serious, and interventional treatment holds significant unmet need. Transcatheter valve replacement appears ripe for surgical robotics, and we expect more companies to enter the market if they can address instrument and imaging challenges.
Figure 6: Heart valve anatomy.
6. Pushing the boundaries of robotic miniaturisation with robotic open microsurgery
Miniaturisation of robotically controlled surgical instruments can be seen in several emerging market segments and is a key feature of robotic open microsurgery systems such as MMI’s Symani and Microsure’s MUSA. 2024 has seen MMI announce the completion of the first clinical cases in the US following FDA commercial authorisation and Sony enter the fray when it unveiled its prototype at the ICRA meeting. These microsurgery systems offer a high degree of motion scaling (up to twenty times), providing surgeons with tremor reduction and increased precision in their instrument manipulation. Microsurgery and ‘supermicrosurgery’ (defined by vessels being <0.8mm in diameter) require very high skill levels and involve long learning curves. RAS systems offer great potential for easing the technical burden on plastic and reconstructive surgeons in complex procedures in oncology, trauma and lymphedema. Currently, this is a relatively uncrowded market segment with high potential for growth.
7. Enabling interventional oncology with image guided percutaneous robotics
Interventional oncology therapy is often called the fourth pillar of cancer care, alongside chemotherapy, radiotherapy and surgery. Therapy is delivered to the tumour through percutaneous, endovascular or endoluminal access. Percutaneous access is typically used when ablating the tumour with a needle probe. This includes methods such as applying cryotherapy to freeze the tumour tissue, radiofrequency energy to heat the tumour tissue or irreversible electroporation to disrupt the tumour cells. Accurate placement of the probe is enabled by 3D imaging. However it is challenging to place the probe along the correct trajectory, and it is complicated by soft tissue movement, for example from patient breathing.
Robotic platforms such as Quantum Surgical’s Epione, build on the advances made with other imaged-guided robotic systems in more mature market segments. This offers advances in the workflow and precision of interventional oncology ablation procedures. As the therapeutic specialty of interventional oncology grows, we expect this segment of the RAS market to grow in turn and competition levels to increase. As with other imaged-guided robotic systems, such as those seen in orthopaedics and spine, a key component will be the software integrating the pre-operative planning, registration and delivery.
Figure 7: Percutaneus ryoablation for the treatment of cancer.
