Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its robotic-assisted CorPath System for use during percutaneous coronary interventions stenting procedures performed via radial access.
The approval was based on results from a 30-patient clinical trial of the device that demonstrated a 100% device and clinical success rate, the Waltham, Mass.-based company said.
“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. 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,” Dr. Ryan Madder of the Frederik Meijer Heart & Vascular Institute of Spectrum Health said in a press release.
Radial access consists of threading a catheter to a patients hart from the radial artery in the patients wrist rather than the femoral artery in the thigh, Corindus said. The technique is being used in approximately 40% of PCI procedures, the company said.
“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,” CEO David Handler said in a prepared statement.
The partnership will allow cath lab physicians and staff to better monitor and protect themselves from excessive radiation exposure, Waltham, Mass.-based Corindus said.
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