February 23, 2015
Cordindus' CorPath System Studied for Robotic-Assisted Peripheral Vascular Interventions
February 24, 2015—Corindus Vascular Robotics, Inc. announced that it has initiated a clinical trial of its CorPath system in peripheral vascular interventions. The trial is a prospective, single-arm, single-center study that will enroll up to 20 patients. The study will assess the safety and effectiveness of the CorPath system in recanalizing lower extremity arterial blockages during peripheral angioplasty procedures.
The Corindus CorPath system is cleared by the US Food and Drug Administration for robotic-assisted coronary angioplasty procedures and is currently indicated in the United States for use in percutaneous coronary intervention (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, the company stated.
The study is currently enrolling patients at the Medical University of Graz in Graz, Austria. The study is led by Prof. Marianne Brodmann, MD, from the university’s Division of Angiology, with Prof. Hannes Deutschmann, MD, of the Medical University of Graz Department of Radiology, and Study Chairman Ehtisham Mahmud, MD, who is with the Sulpizio Cardiovascular Center at the University of California–San Diego.
In the company’s press release, Dr. Mahmud commented, “I routinely use the CorPath system in complex PCI cases, and it reduces my exposure to a significant amount of scatter radiation. 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.”
Prof. Brodmann added, “It was astonishing how easy it was to advance the guidewire and balloon catheter in a precise, controlled manner in the superficial femoral artery. 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.”