Jan 31 2011
Corindus Vascular Robotics has declared that it has received conditional Investigational Device Exemption (IDE) clearance from Food and Drug Administration (FDA) to assess the security and performance of its CorPath 200 System.
In a pivoted trial, the effectiveness of the system in supplying and handling stent/balloon systems and coronary guidewires in percutaneous coronary interventions (PCI) surgeries will be tested. The trial is termed as CorPath Percutaneous Robotic-Enhanced Coronary Intervention Study (PRECISE) and will primarily enroll 154 patients.
Giora Weisz, Co-Principal Investigator, Assistant Professor of Columbia University College of Physicians and Surgeons, has stated that hundreds of PCI surgeries are conducted by interventional cardio surgeons every year. He added that the CorPath 200 system will enable them to demonstrate accuracy of robot-assisted PCI surgeries.
The CorPath 200 System enables robot-assisted positioning of stent/balloon catheters and coronary guidewires from a sophisticated exclusive cockpit. The cockpit of the system is lined with lead, and it effectively protects the surgeon from radiation. The cockpit seat is comfortably placed before the monitor, offering improved image of the angiography screen.
The trial will also focus on testing the capability of the CorPath system in treating the patient without the occurrence of major adverse cardiovascular events (MACE). The radiation exposure of the surgeon during the utilization of CorPath system will be compared with the extent of radiation received during conventional surgical methods.
The pivotal trial will be performed at major hospitals such as Columbia University Medical Center in New York, St. Elizabeth’s Medical Center in Boston, Virginia Commonwealth University Medical Center in Richmond, VA and St. Joseph’s Hospital Health Center in Syracuse, New York. The outcomes of the investigation will serve as basis for Corindus’ Pre-market clearance (510(k)) application to the FDA.
The preliminary trial procedures will be conducted in the beginning of 2011. The first-in-human clinical investigation with CorPath 200 System was conducted by the company in March 2010. These outcomes complied with all the security and efficiency norms of the company. This data was taken into account by FDA while offering conditioning IDE clearance.
Source: http://www.corindus.com