Medical Device Link.

This system and other robotic devices developed or under development by companies such as Computer Motion (Santa Barbara, CA) and Integrated Surgical Systems (Davis, CA) have the potential to revolutionize surgery and the operating room. They provide surgeons with the precision and dexterity necessary to perform complex, minimally invasive surgical (MIS) procedures, such as beating-heart single- or double-vessel bypass and neurological, orthopedic, and plastic surgery, among many other future applications.

The daVinci surgical system from Intuitive Surgical being used in the operating room of the Cardiovascular Institute (Dresden, Germany). ©1999 Intuitive Surgical Inc.

Manufacturers believe that their products will broaden the scope and increase the effectiveness of MIS; improve patient outcomes; and create a safer, more efficient, and more cost-effective operating room. It is the vision of these companies that robotic systems will one day be applicable to all surgical specialties, although it is too early to tell the full extent to which they'll be used.

Surgical robotics manufacturers working toward FDA approval of their devices are encouraged by Intuitive Surgical's recent FDA approval. "The future looks bright," says Yulun Wang, MD, founder and chief technical officer of Computer Motion. "This approval sends a positive signal to industry, and there are tremendous opportunities."

According to Wang, "The goal of robotic surgery is to offer superior quality and reduced trauma to the patient. Today, the skeptical surgeon would say that's not proven yet, but the progressive surgeon would say that these goals are achievable. Thus far, the results have been phenomenal."

And many researchers and industry participants in the field say that the capabilities of first-generation systems are just the beginning. According to Richard E. Wood, MD, chief of cardiothoracic surgery at Baylor University Medical Center (Dallas), robotic surgery systems "will certainly make it easier to perform major surgeries, but these systems still need to evolve. They're not for every patient, but with time we will gain more experience and do more procedures, and the instruments will evolve from this first generation."

Currently, the three principal device manufacturers in this area are Intuitive Surgical, Computer Motion, and Integrated Surgical Systems. Their systems are described below.

The daVinci surgical system from Intuitive Surgical consists of a surgeon's console, a patient-side cart, a high-performance vision system, and proprietary instruments. Using the daVinci system, the surgeon operates while seated comfortably at a console viewing a 10¥-magnified, 3-D image of the surgical field. The surgeon's fingers grasp the instrument controls below the display, with wrists naturally positioned relative to his or her eyes. Intuitive's technology seamlessly translates the surgeon's movements into precise, real-time movements of the surgical instruments inside the patient, without hand tremor, according to the company.

The pencil-sized instruments feature Intuitive's proprietary EndoWrist technology–essentially, computer-enhanced mechanical wrists–that are designed to have the dexterity of the surgeon's forearm and wrists at the operative site, which is accessed through 1-cm ports. The EndoWrist gives the surgeon the ability to reach around, beyond, and behind delicate body structures, and is connected to the rest of the system by sophisticated mechanical cable transmissions. The computer translates the surgeon's open-surgery hand movements into the same movements of the instruments, entirely avoiding the reverse movements of traditional MIS. The wrist can roll, pitch, yaw, and grip, allowing the surgeon a total of seven degrees of freedom for each hand.

According to the company, the daVinci system provides the surgeon with the intuitive control, range of motion, fine-tissue manipulation capability, and 3-D visualization characteristic of open surgery, while simultaneously allowing the surgeon to work through the small ports typical of minimally invasive surgery. Furthermore, it has the potential to make existing MIS operations easier, make difficult MIS operations routine, and make new surgical procedures possible.

"The daVinci system gives the surgeon back the perspective of being inside the operative field, which was lost with laparoscopic surgery," says Barry Gardiner, MD, director of minimally invasive and computer-enhanced surgery at San Ramon Regional Medical Center (San Ramon, CA). Gardiner was involved in the development of the daVinci system in 1996. "The system scales the surgeon's hand and finger movements down to a microsurgical level, allowing for a great degree of accuracy and precision. In laparoscopic surgery, surgeons mostly use their elbows and shoulders, but with the daVinci system, control moves down to the fingertips."

For its FDA approval, the company studied the use of the robotic system on 113 patients who underwent surgery for gallbladder disease or gastroesophageal reflux, then compared the results with those of 132 patients who received standard laparoscopic surgery. Results showed the robotic system was comparable to standard laparoscopic surgery in safety and effectiveness, according to FDA.

While the surgical procedures with the robotic device took 40 to 50 minutes longer than standard laparoscopic surgery, this was attributed, in part, to lack of surgical experience with the new technology. Because of the expected learning curve with the new system, Intuitive Surgical is developing a training program for surgeons, in collaboration with FDA.

The voice-controlled Automatic Endoscopic System for Optional Positioning (AESOP) by Computer Motion.

The Zeus robotic surgical system by Computer Motion will be studied for use in thoracoscopic and coronary artery bypass grafting procedures.

The Hermes control center by Computer Motion is a centralized sytem that enables the surgeon to voice-control a network of medical devices.

Intuitive will also be seeking approval to use its robotic technology for cardiac procedures, including some types of bypass surgeries and valve replacement and repair. The robotic technology is currently in use in Europe for cardiac surgeries and prostate gland removals.

In a German study reported in mid-November 2000, it was found that using the daVinci system to perform endoscopic beating-heart (single or double) bypass surgery is safe, causes significantly less trauma to the patient, and allows for quicker recovery. Stephan Schueler, MD, chief of surgery at the Cardiovascular Institute (Dresden, Germany) reported that of 170 people who underwent the minimally invasive surgery with the device, only eight needed to have the procedure converted to traditional, open-chest surgery. Schueler performed the world's first closed-chest multivessel cardiac bypass in October 1999, using the daVinci system.

Computer Motion has developed an extensive line of surgical robotic systems. The company's products include the voice-controlled Automatic Endoscopic System for Optional Positioning (AESOP); the Hermes control center, a centralized system which enables the surgeon to voice-control a network of computer-controlled medical devices; and the Zeus robotic surgical system for minimally invasive microsurgery procedures.

The Zeus system consists of three interactive robotic arms placed at the operating table, a computer controller, and an ergonomic surgeon console. One robotic arm is used to position the endoscope to provide visualization of the operative site, while the other two robotic arms manipulate surgical instruments under the surgeon's control. While seated at the console, the surgeon can view the operative site in either 3-D or 2-D. The surgeon controls the movements of the endoscope with spoken commands. Movements of the surgical instruments are controlled via handles at the console that resemble conventional surgical instruments.

While seated at the console of the Zeus robotic surgical system (shown here) by Computer Motion, the surgeon can view the operative site in either 3-D or 2-D.

The Zeus robotic surgical system by Computer Motion consists of three interactive robotic arms (shown here), a computer controller, and a surgeon's console.

The Zeus system is CE-marked for commercial sale in the European Union and is comarketed by Computer Motion and Medtronic (Minneapolis). According to company founder Wang, Computer Motion has been approved for six U.S. clinical trials using the Zeus system. The company has completed an FDA-approved Phase I investigational device exemption (IDE) coronary bypass study and has initiated an IDE for mitral valve surgery and general laparoscopic studies, including cholecystectomy (gallbladder removal) and Nissen fundoplication (a procedure to correct acid reflux disease).

The company has also received FDA approval to conduct a new study examining use of the Zeus system for thoracoscopic procedures. During these trials, the Zeus system will be used to mobilize the left internal mammary artery (LIMA) in preparation for routine coronary artery bypass grafting (CABG) procedures. The actual CABG procedures will be performed by conventional methods. Computer Motion hopes to complete enrollment in this study in mid-2001. In addition to these studies, the company is examining the Zeus system for use in fallopian tube reanastomosis.

According to Wang, more than 130,000 patients worldwide have undergone robotic surgery using Computer Motion's systems. The largest opportunities for the company's products are in the areas of beating-heart bypass surgery, complete revascularization of the heart (in conjunction with stenting), and prostate removal, says Wang.

When compared with open surgery, a major problem associated with endoscopic surgery is that it reduces the surgeon's freedom for manipulation. Robotics companies have been working to overcome this limitation. In mid-December 2000, Computer Motion was issued a patent covering design of the company's Micro-Wrist technology, which is integrated into a series of surgical instruments used with the Zeus system in endoscopic surgery. The Micro-Wrist technology allows
six degrees of freedom for the instrumentation at the end of the laparoscope, compared to the seven degrees of freedom possessed by the human hand.

"The Zeus system is designed to facilitate large-scale movements externally that are translated into very precise micromovements internally. With the Micro-Wrist technology, we can offer surgeons increased dexterity by allowing them a wristlike range of motion inside the patient's body," says Wang. "To create our Micro-Wrist instruments, we have taken a proven design approach based on the push-and-pull rod technology with flushing port that is used in today's surgical instruments. This allows us to deliver robotic instruments with a 5-mm-and-smaller diameter that are very durable and easily sterilizable. We now offer a suite of more than 40 Zeus instruments to support a broad range of multidisciplinary procedures."

Computer Motion has formed a number of strategic alliances with medical instrumentation and OR equipment companies (see Table I). These alliances have enabled the company to integrate voice control and robotics into its products and to expand its investment opportunities.

Integrated Surgical Systems

Integrated Surgical Systems (ISS) has developed two image-directed, semiautonomous robotic products for neurological and orthopedic surgical applications. One of these products, NeuroMate, is the first robotic technology for use in stereotactic brain surgery.

NeuroMate consists of a robotic arm assembly and a PC-based planning system. The system was cleared by FDA in July 1999 for use with a frameless head assembly, which is intended to replace the bulky conical frames worn by patients during brain surgery. The frameless system is a light plastic device that holds an ultrasound sensor, which relays signals to the surgical robot about the position of the patient's brain in relation to the robot arm.

The NeuroMate by Integrated Surgical Systems consists of a robotic arm assembly and a PC-based planning system.

The Robodoc surgical assistant system by Integrated Surgical Systems is a computer-controlled surgical robot with specialized hardware for preparing bones for prosthetic implants.

According to Ramesh Trivedi, MD, president and CEO of ISS, the company has installed 18 NeuroMate systems in the United States, Europe, and Japan, and the system has been used in 3000 stereotactic brain surgeries. Thus far in 2001, seven new orders have been placed for NeuroMate systems worldwide. The system and the frameless device are sold together for about $400,000. It is able to interface with other popular planning stations offered by third-party vendors, according to the company.

ISS's other robotic device, the Robodoc surgical assistant system, is used in total joint arthroplasty (surgical shaping or alteration of the joint). The Robodoc system consists of a robotic arm assembly and a PC-based 3-D planning station called Orthodoc.

In mid-December 2000, the company announced that it will begin formal clinical trials for use of its Robodoc system in total hip arthroplasty (THA). The clinical trial will enroll about 180 patients and is expected to take five months to complete. Upon completion, data from the studies will be submitted to FDA for premarket notification (510(k)) clearance. During the procedures, study sites will use the VerSys line of cementless hip prostheses made by Zimmer (Warsaw, IN), a subsidiary of Bristol-Myers Squibb (New York City).

The Robodoc system has been used in 8000 arthroplasty procedures worldwide (including hip and knee), and 40 systems are installed in medical facilities worldwide, according to Trivedi. The system is currently being marketed in Europe and the Middle East.

In October 2000, ISS introduced a total hip system planning application module for its Robodoc system. According to the company, this new module integrates planning of both the acetabulum cup and the femoral stem. Currently, the planning and placement of the acetabular cup itself is a major challenge for orthopedic surgeons as they ream the pelvis and place the acetabular cup by hand. Recently introduced freehand navigational systems offer some assistance by providing visual cues to guide the surgeon's tool to the desired site. However, according to the company, the reaming and placing of the components is still performed by hand and remains a major challenge for surgeons.

According to Trivedi, use of the planning module represents a "major step forward in the process of ensuring successful surgical outcomes for patients undergoing THA. With this new system, the surgeon would take one CT scan of the femur and pelvis, instead of two separate scans. And in only one 3-D planning step, the surgeon plans for the entire hip system in 3-D mode–and not just the cup or the stem, individually and separately."

"If the surgeon wishes," Trivedi adds, "the acetabular cup may be placed using any number of freehand navigational systems from the plan developed on the ISS Orthodoc preoperative planning workstation. However, in the near future, the Robodoc system itself will ream and support placement of the cup, thereby eliminating the need or use for the navigational system and further improving performance and outcome. We anticipate this application, for reaming and placement of the pelvis, will be available next year."

In mid-December 2000, Intuitive Surgical received FDA approval to launch a multicenter clinical trial evaluating the company's daVinci system for minimally invasive mitral valve repair. The company stated that the trial will involve recruitment of about 50 patients at six centers in the United States. The study results should be available by the end of the year, according to Fred Moll, MD, cofounder and medical director of Intuitive Surgical.

Initial studies were conducted by the cardiac team at the University Health Systems of Eastern Carolina/Brody School of Medicine at East Carolina University (ECU; Greenville, NC). The multicenter trial will be led by W. Randolph Chitwood Jr., MD, chairman of the department of surgery at the ECU School of Medicine.

According to a statement by Chitwood, "The patients in our feasibility study who had their mitral valve repaired using this technology experienced much less pain and trauma, better cosmetic results, and spent less time in the intensive care unit and hospital compared with conventional mitral valve surgery where the patient's breast bone is divided in half."

More than 70,000 heart valve repair or replacement surgeries are performed annually in the United States, notes Chitwood. "Although we are in the early stages of developing and applying robotics to cardiac surgery, the future looks promising."

Also in mid-December, Intuitive noted that the daVinci system received Category B-1 reimbursement designation from the Health Care Financing Administration, allowing reimbursement for use of the system in FDA-approved clinical investigations.

Computer Motion is also investigating mitral valve repair and replacement with its Zeus system. The company has initiated a feasibility clinical trial for this application, and is currently enrolling patients.

It is expected that it will take about two to five years for robotic systems to be approved for general cardiac use, according to researchers.

In July 2000, FDA reclassified robotic surgical devices as Class II instead of Class III products, making them eligible for the 510(k) clearance process instead of the longer premarket approval (PMA) process.

Product manufacturers in the robotics industry were thrilled with FDA's decision. "This reclassification was sweet music to our ears," says ISS's Trivedi. "It greatly affects the timing of the market introduction of the Robodoc system in the United States. Now, the biggest market in the world may be accessible in a shorter period of time."

Computer Motion's Wang echoes manufacturers' sentiments. "This decision was very fortunate for us, and we feel it was the right decision. It shows that FDA recognizes surgical robotics as next-generation, advanced surgical instruments combined with already proven (less-invasive) technology."

Intuitive Surgical's Moll hints that FDA's decision could let loose a stream of pent-up creativity in the robotic surgery marketplace. "This decision was appropriate," he notes. "FDA has gone through a process of determining that these products are safe and efficacious–and now industry can move forward."

According to surgeons and device executives, surgeon training is the key to the future success of the robotics industry. Any kind of new technique takes a while to catch on, says Peter Schulam, MD, chief of the division of endourology and laparoscopic surgery at UCLA Medical Center (Los Angeles). Such new techniques commonly encounter resistance until surgeons are shown how the systems can make their jobs easier. Each of the device manufacturers mentioned above has training programs in place to advance the skill sets of both new and established surgeons.

In fact, training in itself can represent an excellent business opportunity. According to Wang, Computer Motion's technology has an important role in telementoring and teleeducation. "Teleeducation on our systems enables surgeon training via remote assistance," he notes. "We have a product in beta testing right now, called Socrates, which is a mentoring product for remote training and assistance. With Socrates, a learning surgeon is accompanied remotely in his or her first surgery by an experienced surgeon, rather than flying solo. This is a very valuable option."

However, Wang says that robotic surgery is a big change from traditional laparoscopic or open surgical techniques, and a two-day course is not sufficient training for surgeons. "Robotics can enable new advanced procedures, and they also have an important role on the training and education side. What's important to note here is that these two functions are complementary: further training can lead to more-advanced procedures, and so on."

In line with Wang's philosophy, Computer Motion has set up a training program called the Evolve Cardiac Continuum, which involves education and personal training on robotic devices, along with cadaveric laboratory training in Europe and the United States. The program "is designed to support a systematic approach from open-chest surgery to endoscopic, beating-heart surgery, supported by an economic and gradient integration of computer and robotic technology," says Wang. The length of the program depends on a physician's experience with video-assisted surgery. Most surgeons will be able to complete the training within one year, and the first step can be accomplished in as little as a week for some surgeons.

According to Moll, robotics systems will have a huge impact on surgical education, and they will be integrated into surgeons' training. "Surgeon training will become comparable to fighter pilot training. It will become a way of objectively measuring skill level, and it will go a long way toward raising the bar of surgical capabilities," he says.

Remote telesurgery is another capability that will be enabled by robotics technology, adds Moll. "Telesurgery is in the future–and not so far away."

Surgeons and device executives agree that first-generation robotics systems have already displayed many advantages over traditional laparoscopic surgery and open surgery, especially in terms of speedier patient recovery and reduced pain. But they also insist that the technology is still evolving and will become more capable with time.

"We're on the cusp of redirecting and improving surgical capability, but we are in the first generation of this process," says San Ramon's Gardiner. "The technology will be applied selectively early on, but as patients begin to insist on the new technology, it will become state-of-the-art and the standard of care for selected procedures." In Gardiner's opinion, as a general surgeon, "basically, the most promising applications for these systems will be in any surgery in which suturing is an important feature."

Continued evolution of robotic surgical systems is inevitable, says Gardiner. "Down the road, as with PCs, the systems will become smaller, lighter, faster, and easier to set up, and this will increase their applications. As with CT scans, you will find uses and needs for the technology in excess of what the projections were, and surgeons will want and need these devices. The surgeon actually does a better, more precise, elegant, dexterous, controlled procedure with robotics, with less tissue damage, which leads to a better outcome."

"In the next five to seven years, almost all ORs worldwide will have robotic assistance of some kind for major surgeries," says ISS's Trivedi. "We will never, ever, replace the surgeon, but robotics will take over a lot of the things they do by hand, with more precision and accuracy."

UCLA's Schulam, who has been using robotic surgical systems since 1995, when the first products were being developed, says that the elaboration of such systems may change the relationships between surgeons and industry. "Robotics are here to stay. However, it will take time for these devices to revolutionize the way surgery is done, and educational programs are the key to their success.

"We need to change how industry and surgeons interact," he continues. "In the past, surgeons have had a consumerlike relationship with the device industry, where the consumer buys the product and is off. But now, what will be required is a much more collaborative relationship, in order to get surgeons to change the way they're used to doing things."

Baylor's Wood is even interested in forming a robotic surgery institute, perhaps within the next year, where surgeons from many specialties can meet and discuss how to bring robotics technology to the next level.

According to surgeons, patients have been asking about robotic surgery, and their feedback has been very positive. This demand is another key to the success of the robotics industry. "People are very informed today, because of the Internet," says Wood. "About 8% of my patients have asked about robotic surgery."

"Frankly, I was very surprised," says Gardiner. "I thought patients would feel robotics is too impersonal, but I have found that not one patient has not wanted it."

The field of surgery has grown in amazing leaps and bounds since anesthesia was first developed and the first surgeries were performed, more than 100 years ago. Now, according to UCLA's Schulam, surgeons and product developers are finding new ways to get inside the patient, rather than the standard large incision. In Schulam's vision of this industry, the robotics revolution requires a different skill set and advanced instrumentation that can perform the functions of the human hand, but at a microsurgical scale. With FDA approval of the first completely robotic surgery system, we are crossing the threshold into an amazing new future.

Surgical robotics systems mark the beginning of a potentially huge wave of surgical applications for robotic technology. With the assistance of surgical robots, surgeons will extend their healing skills to places within the body that are currently out of reach. The continuing evolution of this technology holds the promise of immense benefits in healing that cannot yet be imagined.