Corindus Vascular Robotics, a leading developer of precision vascular robotics, announced today that the clinical trial of its CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) has begun.
The first percutaneous coronary intervention (PCI) procedure using the CorPath 200 System was performed at the New York-Presbyterian Hospital/Columbia University Medical Center in New York and St. Elizabeth's Medical Center in Boston.
Cockpit-Corindus
Jeffrey W. Moses who is the investigator of CorPath PRECISE trial and Professor of medicine, Director of Interventional Cardiology and Director of the Center for Interventional Vascular Therapy has revealed that he was able to perform a PCI procedure for the first time in his career without wearing a lead apron. He further stated that the CorPath’s radiation shielded cockpit supplied the best view of the angiography screen and allowed him to manipulate easily the guidewire and place the stent accurately. According to him, this trial was a ground-breaking trial for patients in the cath lab.
The trial would be carried out on 154 patients in a multi center study and done by a single arm. The effectiveness of the CorPath 200 system in providing and manipulating the stent or balloon systems and coronary guidewires in the PCI procedures would be evaluated by the investigators. The trial would be led by Co-Principal Investigators, Joseph P Carrozza and Giora Weisz. Dr. Carrozza has remarked that he was glad to be in charge of the trial that would take care of the much needed improvement in ergonomics and safety in the cath lab. He revealed that his comfortable sitting position allowed him to focus fully on the physiology of the patient even while accurately controlling the guidewire and stent movements in increments of 1mm. He states that the first case was a resounding success and that he hopes to perform many more procedures using the CorPath.
This trial would be performed at prominent medical centers all over the US and the results obtained from this study would be the base for applying to the FDA for a Pre-market clearance (510k). According to David Handler, the CEO and President of Corindus, the company was delighted to proceed with the trial of the CorPath PRECISE, in the company of leading investigators and renowned institutions.