4th May 2007,The world’s first robotic arm for angioplasty arrived in India at the renowned Dr. LH Hiranandani Hospital, Powai, Mumbai. With this Dr LH Hiranandani Hospital will become the Asia’s first and one of the world’s few centres of excellence to be conducting research on this exciting international breakthrough. The robotic arm allows remote manipulation of Percutaneous Coronary Interventions (PCI).

The Physician Workstation incorporates a touch-screen control console and a joystick. It allows the physician to control the wire and device movements from a remote location.

For the first time in India, Dr. L H Hiranandani Hospital conducted a live demonstration of angioplasty using this robotic arm on the 10th of May to share the highlights of the study. Till date 11 angioplasties have been done using this robotic arm with 100% success rate by Dr Ganesh  Kumar  at this prestigious institute . Simultaneously 5 centers in US are going start enrolling patients for using this path-breaking technology.As part of the multicentric clinical evaluation for US FDA approval, Chief Interventional Cardiologist Dr.Ganesh Kumar of Dr. LH Hiranandani Hospital has been chosen as principal investigator to conduct this study in India.

Earlier in December 2005, Dr. Ganesh Kumar of Dr LH Hiranandani Hospital (Mumbai), teamed up with Rafael Beyar (considered the father of stents) and other eminent members including Tal Wenderow, Doron Lindner, and Rona Shofti, in Israel, to develop and tested this equipment. The result of this path-breaking study was published in Europe’s EuroIntervention journal in November 2005. The study concluded that remote navigation system for coronary interventions including balloon angioplasty and stenting is feasible. The system was tested initially in a glass coronary model with visual feedback of the device movements through the transparent glass. Later a normal coronary sheep model (animal model experiments) was employed to test the safety of the system. The third step was a pilot FIM (First in Man) clinical study, conducted in 15 patients with single coronary artery narrowing. Dr. Ganesh Kumar was part of the first in man pilot study in Romania through which this system was evaluated on fifteen patients with stable angina pectoris and a typical risk of coronary heart disease with 100 percent clinical success and technical results in over 92 percent of cases. This study was a turning point in establishing the potential of such a system and was published in 2006 January in the renowned Journal of American College of Cardiology. Now it arrives in India for the first time.

Many advantages over traditional system

Percutaneous coronary intervention (PCI) is a major method of revascularization for coronary artery disease, with over 2 million coronary interventions performed annually. The majority of interventions (70-80%) are coronary dilatations using stents. Recently, drug-eluting stents (DES) have shown sustained advantage compared to bare metal stents, with a marked reduction of restenosis rates. The catheterization laboratory personnel so far have been operating in an unfriendly environment subject to a continuous X-ray radiation throughout life. This has been unchanged since the beginning of the field of interventional cardiology more than 25 years ago. “Interventionalists’ disc disease” is a well confirmed entity with cardiologists reporting more neck and back pain, more subsequent time lost from work, and a higher incidence of cervical disc herniations, as well as multiple level disc disease owing to the tiresome standing procedure of angioplasty and the heavy weight of the anti radiation gear that takes a toll on the operator.

This robotic remote control PCI system not only helps patients avail services of their preferred doctors over large distances, but also helps physicians operate in an X-ray free and relaxed environment with lesser chances of spinal risk thereby increasing the ability of the operator to deal with long procedural hours. In contrast to the present angioplasty process that requires two cardiologists, the robotic remote control procedure can be conducted without need of assistants making the process more efficient and reproducible and reducing chances of operator-based error.  In this system motors and motion sensors are used to manipulate angioplasty wires, stents and balloons via a joystick and a computer touch screen leading to enhanced precision of balloon and stent-positioning (which may be an extremely important feature in DES therapy). Semiautomatic procedures can also be robotically controlled by the system by obtaining continuous image base feedback data. On-line communication with the patient is obviously of value in generating trust and confidence of the lightly sedated patient and the medical team. The robotic remote-control system allows for doctor-patient interactions with voice and image technology. If for any reason the system malfunctions it can be switched to manual mode in a few seconds.

The current RNS (Remote Navigation System) is the first clinically oriented system for remote manipulation of PCI and allows full navigation of coronary wires and devices in parallel allowing operation in a standardized catheterization laboratory using standard wires and devices that are robotically manipulated and allow for transatlantic communication. This RNS is composed of a bedside unit and a remote manipulation unit. The bedside unit has individual wire and device manipulators capable of precise maneuvering and positioning of the wires and devices.

Future of Cardiac Care is Here

Hiranandani Hospital, Mumbai is considered as a centre for excellence in international quality healthcare and is well known for Primary Angioplasty in Myocardial Infarction (PAMI). Says Dr. Sujit Chatterjee, CEO of Dr LH Hiranandani Multispeciality Hospital, “We are proud that our hospital is chosen to conduct this pioneering study for the first time in India, and Dr Ganesh Kumar as the principal investigator of the world’s first team to have worked on creating such a system. We are very excited of a future possibility wherein our doctors can conduct angioplasties from our hospital when the patient in another remote location and couldn’t be transported in time to our hospital due to any reason, through the help of precision controlled robots….such a process will indeed bring about a revolutionary era in cardiac interventions. This I am sure will come about within a decade. Indian doctors like Dr Ganesh Kumar will lead the way.”

Says Dr. Ganesh Kumar, Chief Interventional Cardiologist at Dr. L H Hiranandani Hospital “What was science fiction yesterday is fast becoming reality. With the positive results of the revolutionary studies, I am hopeful that the day is not far away when robotic remote control angioplasty will be the preferred procedure in coronary care bringing many far reaching advantages to the public.”

Robotic Percutaneous Intervention

Robotic Percutaneous Intervention places discrete technology at the fingertips of interventionalists; uniting the physician's distinctive skill set with robotic precision, while allowing for cases to be conducted remotely from a safe, comfortable location .


CLINICAL BENEFIT
Interventional physicians are among the most highly trained operators in the field of noninvasive surgery; Robotic Intervention utilizes the physician's existing techniques while incorporating an additional level of control through the use of robotic technology. This combination introduces the exactitude of robotic precision to interventional procedures and is expected to produce better clinical outcomes in the drug eluting stent era.


REDUCEING X-RAY EXPOSURE
In the last 30 years Percutaneous Interventions have been performed using X-ray guidance for angiographic imaging. A high level of exposure to medical professionals is a fundamental concern which has grown with the marked rise in case load in the past decade. Remote controlled technology significantly reduces x-ray exposure to operators.


ELIMINATEING OPERATOR NECK AND BACK AILMENTS: INTERVENTIONALIST'S DISC DISEASE
The use of lead protective garments, and the related health problems known as “Interventionalist's Disc
Disease,” is a major problem for operators and staff. Severe physical ailments are associated with prolonged use of heavy lead attire causing preventable pain and disability. Remote controlled technology provides a safe and comfortable working environment while assuring procedural accuracy.

Features and Benefits

The Robotic Remote Control System utilizes standard femoral access to deliver off the shelf interventional devices

1.Enhanced accuracy through robotic assisted wire/catheter maneuver and precise control

2.Improved quality of life, extending physicians' productive years
•  Reduces cancer risk associated with radiation exposure
•  Reduces potential spinal injuries associated with frequent/long use of heavy lead garments

3.Quick installation of portable system minimizes cath lab downtime and maximizes productivity

4.Minimal learning curve for cath lab staff

5.Compatible with standard cath lab products and imaging systems.

Corindus CorPath

“The Corindus CorPath™ system allows physicians to advance and torque coronary guide wires and stent systems in a patient's artery from a remote location. Corindus will bring the simplest, most intuitive remote control capability to every catheterization laboratory room providing the physician with a safe and convenient operating environment ” .

Corindus:

Corindus designs, manufactures and commercializes patented remote control systems for interventional cardiology. Its CorPath™ system enables the physician to perform catheterization procedures from a remote location beyond the radiation zone. Compatible with state-of-the-art cardiology products and cath lab imaging technologies, CorPath™
mechanically maneuvers devices through patients’ arteries as specified by the physician at a remote workstation. The proprietary technology utilizes physician fluoroscopic control similar to routine practice to allow maneuvering and torquing of cath lab devices. Initial clinical trials have demonstrated CorPath’s safety and efficacy. Unique to CorPath™ is the simplicity of integration into existing cath lab systems.

The CorPath™ system requires regulatory clearance and currently is used for investigational purposes only.

CorPath:

The CorPath™ Robotic PCI System is comprised of a Bedside Unit and a Physician Workstation. The system enables the physician to operate precise robotic technology from a remote and safe location. The Bedside Unit easily mounts on the side bar of all standard catheterization procedure tables and swings into position over the patient's femoral access site, it is designed to mechanically maneuver guide wires and balloon/stent systems with various motion mode options. Devices can be maneuvered rotationally, axially, or simultaneously, utilizing discrete touch screen technology. The motion mode is specified by the physician at the Physician Workstation.

With Robotic PCI the guidewire is maneuvered utilizing both a joystick and touch screen. Axial and rotational guidewire motions are achieved by exchanging a torqueing device in the physician's hand for a joystick that has similar characteristics and transmits hand movements through mechanical transmission to the CorPath™ robotic arm. There are also options for continuous mode and discrete-step wire rotations and balloon/stent placement to within 0.5 mm on the touch screen.

CorPath™ has been designed with a mechanism that locks the guidewire in position when the balloon/stent is being manipulated, and vice versa.