Corindus Vascular Robotics, Inc., a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has given 510(k) clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions (PCIs) performed via radial access.
The 510(k) clearance was based on results of a clinical trial conducted at Spectrum Health, Grand Rapids, Mich., and St. Joseph's Hospital Health Center, Syracuse, N.Y., with an enrollment of 30 patients that demonstrated 100 percent device and clinical success.
The radial approach for PCI has been steadily growing in popularity and is now utilized in approximately 40 percent of PCIs in the U.S. During radial PCI, the physician threads a catheter to the patient's heart from the radial artery at the patient's wrist rather than into the femoral artery at the patient's upper thigh. The radial approach delivers similar procedural success as femoral PCI procedures but with fewer access site or vascular complications. Studies also demonstrate that radial PCI procedures can significantly reduce hospital stays and associated costs as patients are able to return home shortly after the procedure. While radiation exposure to patients during PCI procedures is similar regardless of access site, the REVERE trial1 demonstrated that interventional cardiologists are exposed to significantly higher levels of radiation while performing left-radial as opposed to femoral access procedures.
"Radial access is a critical technique to improve patient experience and reduce post procedural complications. It will doubtless become the predominant approach in the U.S. as it has abroad," said Ryan Madder, MD, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute of Spectrum Health. "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. Minimizing operator radiation in these cases is particularly important considering that some studies have shown radial access to be associated with increased radiation exposure."
"The FDA's clearance for radial access PCI with the CorPath System is a significant step in the adoption of robotic PCI. We are looking forward to further expand the use of the CorPath System enabled by this new clearance. The CorPath System's ability to protect cath lab personnel during these cases is more important than ever with the increasing prevalence of radial and complex PCI in today's cath lab," said David Handler, President and CEO, Corindus.