FDA gives conditional approval for pivotal study to evaluate robotic-assisted placement of coronary guidewires and stent/balloon catheters

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Corindus Vascular Robotics announced FDA conditional Investigational Device Exemption (IDE) approval to evaluate the safety and effectiveness of its CorPath 200 system in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions procedures. With this approval, Corindus is authorised to begin its pivotal trial, CorPath PRECISE. The trial is a prospective, single-arm, multicentre study, which will initially enrol 154 patients.

“Interventional cardiologists perform hundreds of percutaneous coronary interventions procedures each year,” said Giora Weisz co-principal investigator, assistant professor, Columbia University College of Physicians and Surgeons, New York, USA. “By utilising the CorPath system, we hope to demonstrate both precision and accuracy of robotically-assisted percutaneous coronary interventions procedures.”

 

Interventional cardiologist’s daily exposure to radiation and the physical stresses inherent in the cath lab, while performing percutaneous coronary interventions procedures, can lead to occupational health risks— including orthopaedic problems, cataracts and cancer, according to recent data published in the Catheterization and Cardiovascular Intervention journal. The CorPath 200 system allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimised interventional cockpit. The cockpit protects the operator from radiation exposure. The comfortable seated position in front of the “slaved” monitors provides enhanced visualisation of the angiography screen while reducing fatigue and minimises head, neck and back strain.

 

While the clinical endpoint of the trial is the ability to treat the patient without the incidence of major adverse cardiovascular events, the trial will be closely monitoring the radiation exposure of interventional cardiologist while using the CorPath technology compared to the radiation exposure if the operator was performing the procedure at the table.

 

“Improving precision of percutaneous coronary interventions procedures and the ergonomic conditions of the cath lab will ultimately improve patient procedures,” said Joseph P. Carrozza, co-principal investigator and chief of Cardiovascular Medicine at St. Elizabeth’s Medical Centre in Boston.

 

The CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) trial will be conducted at leading medical centers across the United States, including Columbia University Medical Centre in New York, St. Elizabeth’s Medical Centre in Boston, Virginia Commonwealth University Medical Centre in Richmond, Va., and St. Joseph’s Hospital Health Centre in Syracuse, New York. The results of this study will be the basis for pre-market clearance (510(k)) application to the FDA.

 

The first procedures in the trial are targeted for early 2011. Previously, Corindus Vascular Robotics completed its first-in-human clinical trial with CorPath 200 System in March 2010. These results met the company’s safety and efficacy endpoints and were among the data the FDA considered in granting conditional IDE approval.