PARIS – Interventional cardiologists are as pleased to see the arrival of a robotic assistant as the workers at the Fukushima nuclear power plant meltdown site.
A study published by the American Heart Association in August 2016 demonstrated a direct relation between working in a catheterization lab and developing radiation-induced cancer, cataracts and skin lesions. Wearing a lead-lined apron that weighs 25 pounds for 12-hour work shifts also increases the risks of aggravated orthopedic and muscular conditions.
"I have lost several colleagues to brain cancer," Alain Cribier told Medical Device Daily. "We all have musculoskeletal problems."
The pioneering cardiologist from the University Hospital of Rouen, who implanted the first aortic heart valve using a catheter in 2002, Cribier is a member of the advisory board for Robocath SAS, also based in Rouen. He has no financial interest in the company but an enthusiasm for the system that makes him a natural key opinion leader.
"This is not a gadget; it meets a real clinical need because we can not continue to accept working in conditions that put our lives in danger," he said. "You don't feel anything, the radiation is not painful, but there is an accumulation of dose when you do this for decades, day-in and day-out."
According to the published study, cardiologists accumulate significant lifetime radiation exposure in the range of 50 milliseverts to 200 mSv, which corresponds to a whole body dose equivalent to 10,000 chest X-rays.
"When you are performing a procedure, your hands are here with the guidewire, your eyes are here looking at the angiogram, and the X-ray projector is here, just in front of your head," he said, standing at the demonstration model of a cath lab on the exhibition floor at EuroPCR 2017.
Walking away from the model of the Robocath R-One robot to the safety of the radiation shielded control panel, Cribier tapped the chair and smiled, saying, "Now we can sit down."
"The robot does not perform anything itself, everything is controlled by the operator's hand," he said. "This is not a totally new idea. There are surgical robots, orthopedic robots, robots for brain surgery. But it was not considered possible for cardiology. I was skeptical myself when they came to meet with me, but over 10 years I have followed their progress step by step as they solved technical problems."
"Now I can do exactly the same things using the robot that I would do with my hands, advance the wire, retreat, rotate and push," he said.
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The R-One is not the first robot for cardiology. Waltham, Mass.-based Corindus Vascular Robotics offers two models approved by the U.S. Food and Drug Administration, and this month the company celebrated what it called a milestone for the 100th percutaneous coronary intervention (PCI) performed using the second generation Corpath GRX System.
Robocath is working through preclinical trials projecting CE mark approval in 2018 and a submission to the FDA in 2019.
The company estimated there are 16,000 cath labs worldwide performing a total of four million PCI procedures annually.
Though competitor Corindus has a CE mark, the company has yet to sell Corpath robots in Europe, and according to Robocath President and founder Philippe Bencteux, they will not be successful doing so because the accessory cartridge is too expensive.
The sterile, single-use cartridge is an integral part of the robotic mechanism containing the graspers that advance and turn the catheter. It arrives in a sterilized package but is impossible to clean to cath lab quality standards, so a fresh cartridge is required for the next procedure.
Robocath has engineered what Bencteux called a "really cheap disposable" cartridge that will prove to be a differentiator in the market.
A second differentiator is the ability to advance and rotate the guide-wire simultaneously, which he said the Corpath robot cannot do.
"Threading a needle using Corpath, you can turn but not push, or you can push but not turn. We can do both," he explained.
R-One is also easier to use, he said, with one-click introduction of the guide wire.
"It takes two seconds, and the physician can go behind the shield and start. Corpath is not so user-friendly with lots of mechanical steps that complicate the set-up," said Bencteux.
Cribier said he expects in a next step the robot can be applied to peripheral artery procedures as it uses the same sized wire. Corindus has been granted an extended indication by the FDA to apply the Corpath for peripheral procedures.
As for the transcatheter aortic valve replacement procedures that he pioneered, Cribier said, "There is no question the system can be adapted to accept these larger catheters. This system will allow physicians to go anywhere on the vascular highway."
At EuroPCR, Robocath reported it had raised €4.7 million (US$5.2 million) in fresh capital in a financing round led by M Capital Partners from Toulouse, France and Normandie Participations, a regional economic development agency based in Rouen, that also included existing investors who had injected €1.8 million ($2 million) in two seed funding rounds. Robocath has also received financial support of €1.6 million ($1.8 million) from the French national innovation agency Bpifrance.