NATICK, Mass.--(BUSINESS WIRE)--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) procedures using the CorPath 200 System were performed at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York and St. Elizabeth’s Medical Center in Boston.
“For the very first time in my career I was able to perform a PCI procedure without wearing a lead apron,” said Jeffrey W. Moses, M.D., investigator of the CorPath PRECISE trial, director of Interventional Cardiology at NewYork-Presbyterian Hospital, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and professor of medicine at Weill Cornell Medical College, New York, N.Y. “The CorPath System’s radiation shielded cockpit provided an optimal view of the angiography screen and allowed me to easily manipulate the guidewire and accurately place the stent. I was impressed — this trial has the potential to significantly impact how we care for patients in the cath lab.”
The trial is a prospective, single-arm, multi-center study, which will initially enroll 154 patients. Investigators will evaluate the safety and effectiveness of the CorPath 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in PCI procedures. The trial is lead by the Co-Principal Investigators Giora Weisz, M.D., co-director of clinical services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of medicine at Columbia University College of Physicians and Surgeons, New York, N.Y., and Joseph P. Carrozza, M.D., Chief of Cardiovascular Medicine at St. Elizabeth’s Medical Center, Boston, Mass.
“I am pleased to lead and take part in a trial that is addressing a long time need in the cath lab—improved safety and ergonomics,” said Dr. Carrozza. “The comfortable seated position allowed me to focus solely on the patient’s physiology, while I was able to precisely control the guidewire and stent movements, even in 1 mm increments. Our first case was successful, and I look forward to performing more procedures using CorPath.”
The CorPath PRECISE trial will be conducted at leading medical centers across the United States, including NewYork-Presbyterian/Columbia, St. Elizabeth’s Medical Center, Virginia Commonwealth University Medical Center in Richmond, Va., St. Joseph’s Hospital Health Center in Syracuse, N.Y. and Swedish Medical Center in Seattle. The results of this study will be the basis for a Pre-market clearance (510(k)) application to the FDA.
“We are very excited to be underway with the CorPath PRECISE trial with such world-renowned, prestigious institutions and investigators,” said David Handler, president and chief executive officer of Corindus Vascular Robotics. “The enrollment of the first U.S. patients represents another milestone for this technology.”
Corindus (http://www.corindus.com) is the global technology leader in robotic-assisted percutaneous coronary interventions. The Company’s CorPath® 200 System is the first medical device that offers interventional cardiologists complete PCI procedure control from an interventional cockpit. The CorPath open-platform technology and intellectual property will enable Corindus to address other segments of the vascular market, including peripheral, neuro and structural heart applications.
NOTE: The CorPath 200 System is an investigational device and limited by federal law to investigational use only.
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