Corindus Announces First Results for CorPath 200 System

September 20, 2010—Corindus Vascular Robotics (Natick, MA) announced the results of the first clinical study 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. All eight patients in the study were discharged with > 30% stenosis after their procedures, and a 30-day follow-up was completed without occurrence of any major adverse cardiac events (MACE). Juan F. Granada, MD, was the study's principal investigator.

According to the company, the system's ergonomic design provides an environment that improves the physician's ability to focus, enhances visualization, and offers precise robotic-assisted control. The design allows a physician to perform an entire PCI procedure precisely and accurately without the pain, distraction, and fatigue of manual procedures.

“The trial reached its primary endpoint of zero MACE at 48 hours,” commented Dr. Granada. “I was impressed by the CorPath 200 system's ability to precisely control and deliver the guidewire and other angioplasty devices to the target lesion. It definitely helped to perform the procedure in a highly controlled manner. Conducting the procedure while sitting in the system's cockpit gave me more control and better focus on my patient than I would have achieved standing alongside the procedure table.”

Investigator Giora Weisz, MD, commented, “The CorPath 200 System allows me to perform a PCI procedure while sitting comfortably in the interventional cockpit without the strain of a heavy lead apron.” Dr. Weisz noted that his exposure to radiation dropped drastically. “During the study, my mean radiation exposure without a lead apron was only 1.81 µGy. That is 97% less than I would have received had I worn an apron and performed the same procedures manually. The system was also very intuitive and easy to use.”

Corindus will next conduct the CorPath PRECISE (Percutaneous Robotically Enhanced Coronary Intervention Study) prospective, single-arm, multicenter, nonrandomized study. The CorPath 200 system is limited to investigational use only, the company advised.