NATICK, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced that the Journal of American College of Cardiology: Cardiovascular Interventions published the results from the first-in-human clinical study of its CorPath® 200 System in the April 2011 issue (2011;4:460–465). The study was designed as a single-arm, open label, prospective trial to evaluate the safety and technical efficacy of the CorPath 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary intervention (PCI) procedures. Initial results of the study were presented in September 2010 at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference.
The study enrolled eight patients with coronary artery disease indicated for elective PCI at the Corbic Research Institute in Envigado, Colombia. The lead-authors of the study, Dr. Giora Weisz, interventional cardiologist at New York-Presbyterian Hospital, director of cardiovascular clinical research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, assistant professor at Columbia University College of Physicians and Surgeons in New York and Dr. Juan Granada, medical director of the Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation (CRF) in Orangeburg, N.Y., utilized the CorPath 200 System to perform the procedures, achieving a technical success rate of 97.9 percent. All patients were discharged home with less than 30 percent stenosis within 24 hours after the intervention, and completed a 30 day follow-up without the incidence of major adverse cardiovascular events (MACE). Additionally, the operators rated the robotic system’s performance as “equal to” or “better” than manual procedures in 97.5 percent of the cases.
Dr. Granada, who led the preclinical studies with the CorPath System, served as the lead investigator. He commented, “The primary endpoints of the trial were achieved in all patients, achieving a 100 percent clinical success rate. The results mark a significant evolution in interventional device technologies as the actual procedural method of PCI procedures has remained unchanged in the last 25 years.”
Another important finding of the study was the reduction of radiation exposure to the operator. According to recent data published in Catheterization and Cardiovascular Intervention Journal, an interventional cardiologist’s daily exposure to radiation and the physical stresses inherent in the cath lab can lead to occupational health risks— including orthopedic problems, cataracts and cancer. Utilizing electronic direct dosimeters, the investigators found the operator’s radiation exposure was 97 percent lower than the levels found at the standard table position.
“As the current practice of interventional cardiology evolves into more complex PCI procedures, there is a need for improved safety and ergonomics in the cath lab while improving the efficiency of the procedure,” said Dr. Granada. “My early experience demonstrated feasibility, safety and procedural effectiveness with the CorPath 200 System that is comparable to manual operation. I am looking forward to receiving the multi-center CorPath PRECISE results to further validate the CorPath technology in day-to-day practice.”
The CorPath 200 System allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit. The lead-lined cockpit protects the operator from radiation exposure. The comfortable seated position in front of the “slaved” monitors provides enhanced visualization of the angiography screen while reducing fatigue and minimizes head, neck and back strain.
“The publication of our first-in-human study in the Journal of American College of Cardiology is further validation from the scientific community that there is a need for improved ergonomics and safety in the cath lab,” said David M. Handler, president and CEO of Corindus. “We are excited to be underway with the CorPath PRECISE trial. As we continue to progress, we feel that CorPath is a potential game-changing technology.”
The CorPath PRECISE trial, led by Dr. Giora Weisz and Dr. Joseph Carrozza, chief of cardiovascular medicine at Steward Health Care System, St. Elizabeth’s Medical Center in Boston, is expected to enlist 175 patients at leading medical centers across the United States. The results of this study will be the basis for a pre-market clearance 510(k) application to the FDA.
About Corindus
Corindus 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. Additional information can be found at: http://www.corindus.com
NOTE: The CorPath 200 System is an investigational device and limited by federal law to investigational use only.