**3. Robotic systems**

**Table 1** demonstrates characteristics of the below presented endovascular robotic systems (**Table 1**).

## **3.1 Magellan system**

The first endovascular robotic system was the Magellan Robotic Catheter system (Hansen Medical, Mountain View, California, USA). It was designed for cardiac ablations. It consists a remote wire and catheter manipulator with two available steerable catheter systems. One with a 6 Fr inner leader catheter with a 180-degree multidirectional articulation and a 9 Fr outer sheath with a 90-degree multidirectional manipulation. The other is a 6 Fr low-profile system with two bending sections created for navigating in smaller vessels. The manipulation is done with different tightening of wires integrated into the catheters. The manipulator is mounted on the operating table and allows advancement, retraction, catheter

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*Catheter Robots in the Cardiovascular System DOI: http://dx.doi.org/10.5772/intechopen.97314*

> **Compatible wires**

> > 0.035

0.014 Any

0.014 Any

Magellan 0.014, 0.018,

**Compatible catheters**

6 Fr or 9 Fr Magellan Robotic catheter system

commercially available 5–7 Fr catheter

commercially available 5–7 Fr catheter

**Therapeutic device delivery**

Robotically stabilized manual delivery

Robotic Rx device delivery

Robotic Rx device delivery

**Navigation Remote** 

Wire and catheter advancementretraction; 6Fr catheter 180° multidirectional angulation; 9Fr catheter 90° multidirectional angulation

Rx-device advancement, retraction; Wire advancement retraction, rotation

Rx-device advancement, retraction; Wire advancement retraction, rotation; Guide-catheter advancement retraction, rotation **capability**

No

Yes

Yes

**Robotic system**

CorPath 200

CorPath GRX

**Table 1.**

was acquired by Auris Health Inc.

*Technical summary of endovascular robotic systems.*

**3.2 CorPath 200**

bending and rotation of the system also. The control panel is located outside of the operating room. It had a console and monitors to show the real-time fluoroscopic images and the catheter orientation as well. The disadvantage of the system is that the therapeutic devices cannot be delivered remotely it has to be done manually with robotic support. The system is approved by the FDA and CE marked, but it is not widely adopted and also not available commercially [8], later the technology

The CorPath 200 robotic system is an endovascular, remotely guided system primarily developed for percutaneous coronary intervention purposes. The first publication appeared in 2011 using it for a coronary angioplasty. The system has two major components: a bedside unit and the interventional cockpit. The cockpit is a mobile radiation-shielded station to perform the intervention. It has two joysticks for device manipulation and monitors for real-time information about the patient's vitals and the actual procedural field (fluoroscopic and subtracted images). This allows an operator to perform an intervention remotely from the cockpit. The robotic arm is mounted to the table and contains the robotic drive and the attached single-use cassette (**Figure 2**). The arm is flexible, so an optimal angle positioning to the access site is achievable. The single-use cassette holds the wire, stent or balloon if loaded into the system and it is connected to a guiding catheter. In order to establish a stable connection with the guide catheter, it has a support track that prevents bending or bleeding while manipulating with the catheter. The cockpit and the robotic drive are connected via communication cables. The system is compatible with 0.014-inch guidewires, rapid exchange (RX) catheter, balloon


*Catheter Robots in the Cardiovascular System DOI: http://dx.doi.org/10.5772/intechopen.97314*

#### **Table 1.**

*Latest Developments in Medical Robotics Systems*

**2. Robotic assistance and radiation protection**

source receiving smaller amount of dose levels [7].

The demand for minimally invasive procedures is rapidly increasing. In an endovascular era, the radiation exposure is a crucial factor while performing these procedures on a day-by-day basis. There are several techniques currently available to reduce radiation, but robotic-assisted procedures are considered a different approach. The technique's advantage is that the operator does not have to be next to the patient [4]. The operator can sit behind radiation-shielded platform or away from the operating room by wireless connection (**Figure 1**) without the need of wearing a lead apron [6]. The greatest reduction of radiation is therefore on the primary physician, but the assistants can also keep more distance from the radiation

**Table 1** demonstrates characteristics of the below presented endovascular

*Robotic console workstation with radiation shielding. The monitors show live fluoroscopy images and patient* 

The first endovascular robotic system was the Magellan Robotic Catheter system (Hansen Medical, Mountain View, California, USA). It was designed for cardiac ablations. It consists a remote wire and catheter manipulator with two available steerable catheter systems. One with a 6 Fr inner leader catheter with a 180-degree multidirectional articulation and a 9 Fr outer sheath with a 90-degree multidirectional manipulation. The other is a 6 Fr low-profile system with two bending sections created for navigating in smaller vessels. The manipulation is done with different tightening of wires integrated into the catheters. The manipulator is mounted on the operating table and allows advancement, retraction, catheter

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**3. Robotic systems**

**Figure 1.**

**3.1 Magellan system**

robotic systems (**Table 1**).

*vitals (© Corindus Inc., used with permission) [5] .*

*Technical summary of endovascular robotic systems.*

bending and rotation of the system also. The control panel is located outside of the operating room. It had a console and monitors to show the real-time fluoroscopic images and the catheter orientation as well. The disadvantage of the system is that the therapeutic devices cannot be delivered remotely it has to be done manually with robotic support. The system is approved by the FDA and CE marked, but it is not widely adopted and also not available commercially [8], later the technology was acquired by Auris Health Inc.

#### **3.2 CorPath 200**

The CorPath 200 robotic system is an endovascular, remotely guided system primarily developed for percutaneous coronary intervention purposes. The first publication appeared in 2011 using it for a coronary angioplasty. The system has two major components: a bedside unit and the interventional cockpit. The cockpit is a mobile radiation-shielded station to perform the intervention. It has two joysticks for device manipulation and monitors for real-time information about the patient's vitals and the actual procedural field (fluoroscopic and subtracted images). This allows an operator to perform an intervention remotely from the cockpit. The robotic arm is mounted to the table and contains the robotic drive and the attached single-use cassette (**Figure 2**). The arm is flexible, so an optimal angle positioning to the access site is achievable. The single-use cassette holds the wire, stent or balloon if loaded into the system and it is connected to a guiding catheter. In order to establish a stable connection with the guide catheter, it has a support track that prevents bending or bleeding while manipulating with the catheter. The cockpit and the robotic drive are connected via communication cables. The system is compatible with 0.014-inch guidewires, rapid exchange (RX) catheter, balloon

**Figure 2.**

*The CorPath system's robotic arm loaded with a single-use cassette. The whole set-up is mounted to the surgical table (© Corindus Inc., used with permission) [5].*

and stent systems. Additional feature is to measure lesion length by passing the balloon through it then retracting it. The advance and retract functions operate with a 1 mm increment. Through the joysticks the operator can manipulate with the wire and the rapid exchange devices, but the guide catheter control is not available in the CorPath 200. Therefore, a target vessel has to be approached manually. For the wire rotate, advance and retract functions are available, but for the RX devices rotate is not.

#### **3.3 CorPath GRX**

The next generation Corindus robotic system is the GRX. The major advantage is that it includes an active control on a guide catheter. Thus, the catheter has similar features as a wire in the CorPath 200 system, which is advance retract and rotate. This addition involves an extra joystick inserted into the control panel (**Figure 3**). The extent of guide catheter remote movement is 20 cm, therefor the target lesion has to be approached manually by the operator, but crossing the lesion and device delivery can be completed with the robot.

Another feature is the bedside touchscreen on the robotic drive that allows device exchange. This generation of CorPath robots have a turbo button which facilitates faster device movement and also a rotate-on-retract (RoR) function [9, 10]. RoR if turned on is an automated movement of the wire that provides a 270-degree rotation of the wire every time its retracted, which facilitates target vessel/side-branch cannulation mimicking manual rotation of the guidewire.

The newest features of the GRX are the wiggle, spin and dotter options. All of these were implemented based on experts' different lesion crossing techniques. The wiggle oscillates the guidewire upon advance to prevent prolapse in tortuous anatomy. The spin utilizes clockwise and counterclockwise rotation of the guidewire, while the dotter can be used for narrow or calcified lesions based on its small, rapid back-and-forth movements during advance.

Every generation of Corindus robotics are platform independent, which means that they are compatible with every type of operating room or catheter lab suite. The robotic drive is draped to preserve sterility in an approximately 2 minutes. The GRX system has FDA approval and CE marked, currently available to use for percutaneous coronary angioplasties and peripheral vascular interventions. It is commercially available and costs in between 500 and 650 000 USD, plus additional single-use cassette and device costs [11].

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**4. Clinical experience**

**Figure 3.**

*with permission) [5].*

**4.1 Percutaneous coronary interventions**

patients and medical staff also [16].

**4.2 Peripheral vascular interventions**

The first-in-human study regarding coronary angioplasty was published in 2011. Granada and colleagues reported 8 patients, who underwent PCI with the CorPath 200 system. Their data showed a 97% decrease in radiation exposure to the operator with a 97.9% procedural success rate [4]. The first multicenter study with robotic-assisted coronary interventions was the PRECISE study (percutaneous robotically-enhanced coronary intervention) [12]. The study was conducted with the CorPath 200 system and enrolled 164 patients with simple coronary lesions. The inclusion criteria were coronary artery stenosis above 50%, with the diameter in between 2.5–4 mm and with a length that could be covered by one stent. This prospective trial reported a 95.2% decrease in radiation level and a 97.6% success rate. The improvement of the newer generation devices allowed a wider potential application for the robotic assisted therapy as well. The CORA-PCI (Complex Robotically Assisted Percutaneous Coronary Intervention) trial focused on patients with complex coronary artery lesions. Patients were treated by a single operator and a total of 334 PCI-s were analyzed [13]. The results reported a 91.7% technical success and a 99.1% clinical success with robotic-assisted PCI. The study showed that the approach is a viable alternative to manually conducted PCI-s. Regarding postintervention outcomes [14] Walters and colleagues reported non-inferior results in major adverse (cardiac) events at 6 and 12 months also [15]. In 2020, Patel et all. Published their data showing a significant reduction in radiation exposure to

*The new console panel of the GRX system. The three joysticks control the wire, guide catheter and the stent/ balloon. The panel consist a touchscreen that also allows manipulation of the devices (© Corindus Inc., used* 

The first-in-man study evaluating efficacy of robotic-assisted peripheral arterial

lesion cannulation was a prospective, single-armed study by Bismuth et al. [17]. The trial focused on navigating successfully and safely through lesions ranging from simple to complex. The results showed a 100% successful navigation rate

*Catheter Robots in the Cardiovascular System DOI: http://dx.doi.org/10.5772/intechopen.97314*

#### **Figure 3.**

*Latest Developments in Medical Robotics Systems*

*table (© Corindus Inc., used with permission) [5].*

and stent systems. Additional feature is to measure lesion length by passing the balloon through it then retracting it. The advance and retract functions operate with a 1 mm increment. Through the joysticks the operator can manipulate with the wire and the rapid exchange devices, but the guide catheter control is not available in the CorPath 200. Therefore, a target vessel has to be approached manually. For the wire rotate, advance and retract functions are available, but for the RX devices

*The CorPath system's robotic arm loaded with a single-use cassette. The whole set-up is mounted to the surgical* 

The next generation Corindus robotic system is the GRX. The major advantage is that it includes an active control on a guide catheter. Thus, the catheter has similar features as a wire in the CorPath 200 system, which is advance retract and rotate. This addition involves an extra joystick inserted into the control panel (**Figure 3**). The extent of guide catheter remote movement is 20 cm, therefor the target lesion has to be approached manually by the operator, but crossing the lesion and device

Another feature is the bedside touchscreen on the robotic drive that allows device exchange. This generation of CorPath robots have a turbo button which facilitates faster device movement and also a rotate-on-retract (RoR) function [9, 10]. RoR if turned on is an automated movement of the wire that provides a 270-degree rotation of the wire every time its retracted, which facilitates target vessel/side-branch cannulation mimicking manual rotation of the guidewire.

The newest features of the GRX are the wiggle, spin and dotter options. All of these were implemented based on experts' different lesion crossing techniques. The wiggle oscillates the guidewire upon advance to prevent prolapse in tortuous anatomy. The spin utilizes clockwise and counterclockwise rotation of the guidewire, while the dotter can be used for narrow or calcified lesions based on its small,

Every generation of Corindus robotics are platform independent, which means that they are compatible with every type of operating room or catheter lab suite. The robotic drive is draped to preserve sterility in an approximately 2 minutes. The GRX system has FDA approval and CE marked, currently available to use for percutaneous coronary angioplasties and peripheral vascular interventions. It is commercially available and costs in between 500 and 650 000 USD, plus additional

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rotate is not.

**Figure 2.**

**3.3 CorPath GRX**

delivery can be completed with the robot.

rapid back-and-forth movements during advance.

single-use cassette and device costs [11].

*The new console panel of the GRX system. The three joysticks control the wire, guide catheter and the stent/ balloon. The panel consist a touchscreen that also allows manipulation of the devices (© Corindus Inc., used with permission) [5].*
