The FDA has given 510(k) clearance to Corindus Vascular Robotics for its robotic-assisted CorPath System to be used during percutaneous coronary intervention (PCI) performed via radial access. The 510(k) clearance was based on results of a clinical trial, with an enrolment of 30 patients, that demonstrated 100% device and clinical success. The company will be exhibiting at the upcoming TCT conference (booth 1525).
A press release reports that the radial approach for PCI has been steadily growing in popularity and is now used in approximately 40% of PCI procedures in the USA. While radiation exposure to patients during PCI procedures is similar regardless of access site, the REVERE trial demonstrated that interventional cardiologists are exposed to significantly higher levels of radiation while performing left-radial as opposed to femoral access procedures.
The CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to PCI procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance stents and guidewires. The aim of the system, because it enables the operator to perform PCI procedures remotely, is to reduce radiation exposure to the operator.
Ryan Madder, interventional cardiologist at the Frederik Meijer Heart & Vascular Institute of Spectrum Health, USA, says: “Radial access is a critical technique to improve patient experience and reduce post procedural complications. It will doubtless become the predominant approach in the USA as it has abroad. I routinely use the CorPath System in radial PCI and have found it to be useful in reducing my radiation exposure in these radial cases. Minimising operator radiation in these cases is particularly important considering that some studies have shown radial access to be associated with increased radiation exposure.”