Results Published From FIH Telerobotic PCI Procedures With Corindus' CorPath GRX System

September 3, 2019—Corindus Vascular Robotics, Inc. announced results from the first-in-human (FIH) ReMOTE study on the telerobotic percutaneous coronary intervention (PCI) procedures conducted from a remote location outside the catheterization lab using the company's CorPath GRX robotic system technology platform. Tejas M. Patel, MD, et al published the study online in The Lancet journal EClinicalMedicine.

The investigators reviewed the five patient cases performed by Dr. Patel, who is Chairman and Chief Interventional Cardiologist of the Apex Heart Institute in Ahmedabad, Gujarat, India. The five patients underwent elective telerobotic PCI procedures from a distance of approximately 20 miles from Dr. Patel’s location inside the Swaminarayan Akshardham Temple in Gandhinagar, Gujarat. Sanjay Shah, MD, was onsite in the room with each patient at the Apex Heart Institute. In December 2018, Corindus announced that the procedures were successfully conducted.

In the company's announcement, Dr. Patel commented, “I am honored to have been a part of this medical milestone. The application of telerobotics for remote treatment has the potential to impact a significant number of lives by providing access to specialized care that may not otherwise be possible. I am pleased to share my experience with the clinical community in such a well-respected publication that is part of The Lancet family.”

The CorPath GRX telerobotic interventional platform is designed to improve patient outcomes and broaden access to high-level care by delivering highly specialized and timely cardiovascular care to underserved patient populations with geographic barriers to treatment. The company is working on product development to enable use of the CorPath system in remote interventions and expand the company’s robotic platform to address stroke care.

As summarized in EClinicalMedicine, the five patients with single type A coronary artery lesions treatable by PCI consented to participate in the FIH study. The primary endpoint was procedural success with no major adverse cardiac events (MACEs) before discharge. Procedural success was defined as achieving < 10% diametric stenosis of the occluded target vessel utilizing telerobotic PCI balloon angioplasty and stent deployment with CorPath GRX without converting to in-lab manual PCI by an on-site standby team. Procedural, angiographic, and safety data were collected, as were questionnaire scores from the remote operator evaluating the robot-network composite, image clarity, and overall confidence in the procedure.

The investigators reported that the primary endpoint was achieved in 100% of patients. No procedural complications or adverse events occurred, and all patients were discharged the following day without MACEs. The operator scores were favorable, with the operators rating the procedure as equivalent to an in-lab procedure. Performing long-distance telerobotic PCI in patients with coronary artery disease is feasible with predictably successful outcomes if reliable network connectivity and local cardiac catheterization facilities are available, concluded the investigators in EClinicalMedicine.