Nearly four years ago, the FDA granted 510(k) clearance to the CorPath system, making it the first system designed for robotic-assisted PCIs. The system allows operators to perform the interventional procedure by remotely controlling coronary guidewires, balloons and stents. They sit in a cockpit away from the patient, helping reduce their radiation exposure.
Still, robotically assisted PCI remains relatively uncommon. To date, Corindus Vascular Robotics, Inc. has installed 40 CorPath systems, including 37 in the U.S. During the first quarter of 2016, Corindus increased its revenue to $1.1 million, up from $800,000 in the same period last year.
Results of a recent study may help change opinions about the CorPath system. The researchers found that the clinical success rates were above 99 percent and similar in patients undergoing robotically assisted PCI or manual PCI. The findings were presented at the Society for Cardiovascular Angiography and Interventions scientific sessions on May 4 in Orlando.
The technical success rate was 91.7 percent with the CorPath system. The researchers defined technical success as successfully performing the procedure robotically or with minimal manual assistance.
The mean procedure time was approximately eight minutes longer with the CorPath system. However, the difference in procedure times were only for low complexity coronary lesions, according to lead researcher Ehtisham Mahmud, MD, of the University of California, San Diego School of Medicine.
Mahmud added that using the CorPath system did not require additional resource utilization and did not expose patients to an increase in radiation. They evaluated 108 robotically assisted PCIs for 157 lesions and 226 manual PCIs for 336 lesions.
“We were able to demonstrate safety and feasibility of complex robotically assisted PCI,” Mahmud said at a news conference. “We feel that this trial definitively establishes this as an alternative to manual PCI and, importantly, now represents a viable option to address the orthopedic and radiation risk for interventional operators.”
Previous studies found that operators become comfortable with robotically assisted PCIs after three to five procedures. However, Mahmud said that that learning curve only applies to simple coronary lesions.
“Our data cut demonstrates that about 25 cases for the more complex lesions is probably the appropriate learning curve,” he said.
The researchers are currently conducting a detailed analysis comparing the costs of robotically assisted PCIs and manual PCIs. Mahmud noted that disposable cartridges used with the CorPath system cost approximately $600 apiece. Hospitals or practices also incur a one-time expense of purchasing the robot, according to Mahmud.
He added that there were “no clear advantages” for patients of robotically assisted PCI over manual PCI. Still, operators benefit from using the CorPath system, which is also approved for use during PCIs performed via radial access and in peripheral vascular interventions.
“The primary advantages are for the operator doing the procedure and essentially eliminating not only the radiation-associated risk but the potential orthopedic injury because you don’t have to wear lead and you’re not standing up all day when we have a busy day in the cath lab,” Mahmud said. “Those are the clear advantages, and there is no compromise from a patient care standpoint. The clinical outcomes are comparable. I think there’s safety for the patient, there’s efficacy that’s comparable to manual, but the primary benefits are for the operators.”