Corindus Vascular Robotics, Inc., a leading developer of precision vascular robotics, announced today that it has initiated a clinical trial of its CorPath System in peripheral vascular interventions.
The study is currently enrolling patients at the Medical University of Graz in Graz, Austria, and is led by Prof. Dr. Marianne Brodmann, MD, a leading researcher within the university’s Division of Angiology, in combination with Prof. Dr. Hannes Deutschmann, of the Medical University of Graz Department of Radiology, and study chairman, Dr. Ehtisham Mahmud, director, Sulpizio Cardiovascular Center-Medicine, UC San Diego.
“I routinely use the CorPath System in complex PCI cases and it reduces my exposure to a significant amount of scatter radiation,” said Dr. Mahmud. “The value of precision and protection afforded to physicians performing PCI through robotic technology is considerable. As peripheral vascular procedures are lengthy and often complex, the ability to translate the effectiveness of robotic technology to peripheral interventions has tremendous potential to be of benefit to both patients and physicians.”
The trial is a prospective, single-arm, single-center study that will enroll up to 20 patients. Researchers participating in the study will assess the safety and effectiveness of the CorPath System in recanalizing lower extremity arterial blockages during peripheral angioplasty procedures.
“It was astonishing how easy it was to advance the guidewire and balloon catheter in a precise controlled manner in the superficial femoral artery,” said Dr. Brodmann. “The results of this trial can mean the extension of the CorPath System’s capabilities to a greater range of procedures to further transform care delivery in the cath lab.”
“The potential for interventionists to utilize the precision of robotics for peripheral vascular intervention may have significant implications for the care they provide to their patients, and their own health as well,” said David Handler, President and CEO, Corindus Vascular Robotics. “As concern about the risks of cumulative radiation exposure continues to grow for operators in the cath lab, an expansion of the CorPath System’s indications, if enabled by a successful clinical trial, would increase the number and variety of cases that can be performed under the protection of CorPath, which can be significantly beneficial to physician health.”
Developed by Corindus Vascular Robotics, the CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to coronary angioplasty procedures. The CorPath System is currently indicated in the US for PCI only. During the procedure, the interventional cardiologist sits in the radiation-shielded interventional cockpit and advances stents and guidewires with millimeter by millimeter precision.