A surgical robotics firm believes it has a product that can improve outcomes for coronary artery procedures while also protecting physicians from exposure to harmful radiation.
|The CorPath Control Console inside the Interventional Cockpit in A Cath Lab|
The interventional cardiology market in the U.S. is on a downward trend due to a combination of factors such as concerns regarding overuse of stenting and high cost for these procedures.
Still, a vascular robotics company with an approved product hopes that hospitals will choose its robotic surgical system to conduct angioplasty and percutaneous coronary interventions in the U.S. in the future.
Corindus, founded in Israel and based in Waltham, Massachusetts, has developed the CorPath Vascular Robotics System which aims to provide a safer, better alternative to the manual angioplasty and PCI procedures. Better in terms of clinical outcomes for the patient and safer for the interventional cardiologist who is exposed to harmful radiation during the procedure.
In the traditional cardiac catheterization lab, the interventional cardiologist wears heavy leaded garb to limit their exposure to harmful radiation, explained Corindus CEO David Handler in a recent interview. Every so often, the cardiologist who is bent over the patient has to look up at X-Ray imaging machines that are several feet away to see the anatomy of the patient and then manipulate the guidewires, balloons, meshes and stents manually.
Often what happens is that the physician is unable to accurately know the length of the lesion that needs stenting, and ends up choosing a stent that is too short. That requires another expensive stent - made by the likes of Abbott, Medtronic and Boston Scientific - to be deployed. The problem is that Medicare and private payors reimburse providers on a per lesion basis irrespective of whether one or two stents were used to treat it.
|The Interventional Cockpit and Control Console|
The CorPath Vascular Robotics System addresses both the problems currently being faced in the cath lab, Handler said. One it prevents the need to have cardiologists and other hospital staff wear heavy, joint-straining lead garb to protect from radiation exposure. And second, the system aids in knowing the exact lesion measurement, so that physicians are not having to guess lesion length that often can lead to wrong stent choices.
How is that possible?
In the first instance, the CorPath System has the cardiologist seated at a cockpit on wheels that contains the control console to manipulate the robotic surgical evice. The cockpit also houses screens through which he or she can get real time images of the anatomy being treated. The cockpit has lead glass and lead-lined walls and as such the cardiologist sitting in it to perform the robot-assisted intervention is protected from radiation exposure.
At the same time, cables connect the cockpit and console to the robotic drive that is at the end of an arm mounted on the patient’s bed rail. The drive contains a disposable, sterile cassette in which the cath lab technician can load the equipment needed for the angioplasty or coronary intervention including the guidewire and the stent.
The drive is constructed such that it is compatible with all manufacturers’ stents and guidewires, Handler said.
Seated at the cockpit, the cardiologist can use the two joysticks to control the robotic drive and using the imaging right in front of him to see when he has reached the beginning of the lesion. At that point of time, he can press a button to let the system know that the lesion has begun.
|The CorPath Bedside Unit and Robotic Drive|
The robotic system can keep track of how far the lesion stretches as the physician manipulates the drive and the guidewire.
“The way we do that it that our system is measuring the movement of the guidewire, the balloons and the stents in sub-milimeter accuracy and it reads that out on the screen so that the doctors can see exactly how far they are moving,” Handler explained. “So the system can be used just like a trip odometer in your car to track how far it is from the beginning of a lesion to the end of a lesion.”
Once the X-ray image in front of them shows that they have reached the end of a lesion, they can press another button to have a readout of the lesion size. That helps to determine the length and type of stent that they should choose.
Using more than one stent to treat a lesion, which happens not unfrequently, is not considered clincially ideal. Thus the ability to know the lesion measurement that guides the choice of the stent size, cannot be underestimated, Handler said.
“Overlapping stents are not necessarily the ideal clinical treatment for the patient,” he said. “[On the other hand] if one stent chosen is too long and they deploy it, it can end up blocking a side branch because the coronary artery is like a tree - there are big branches and there are small branches.”
The CorPath system thereby helps to address the issue of lesion measurement accuracy.
“If they are able to use fewer stents and accurately treat the patients, it’s better for the patient and better for hospital economics,” he said, given that hospitals get reimbursed for the number of lesions they treat and not how many stents or other equipmnt were used.
A clinical trial testing the CorPath has shown that the system reduces the amount of contrast dye needed to provide a continuous image of the anatomy when compared with traditional, manual treatment procedures, Handler noted.
“The measurement capability allows doctors to do the lesion assessment in a predictable way. You don’t need to be puffing the dye as often,” Handler explained “The control of the device gives them extra predictability in the navigation through the coronary artery which again reduces the times they need to puffing contrast.”
For these reasons, Handler believes that hospital administrators will be open to installing the CorPath Vascular Robotics Systems in their cath labs. He added that compared to other surgical robotics systems that can cost any where from $800,000 to about $2 million, the CorPath costs less than $500,000. Each disposable cassette costs $800.
So far 20 systems have been sold to many different types of hospitals like those in big cities, to academic centers to community hospitals. And unlike new systems that require special construction in the cath lab, CorPath is fairly easy to install.
“Our system doesn’t require any construction, so the installation is very easy to facilitate in the hospital, which is part of the whole economics story," Handler said.
[Images Credit: Corindus Inc.]